Multiple Myeloma
Conditions
Keywords
Antibody drug conjugate, Dose-escalation, GSK2857916, Japanese, Relapsed/Refractory Multiple Myeloma
Brief summary
Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation antigen (BCMA) expressed on tumor cells of all participants with multiple myeloma. This is a Phase 1, open label, dose escalation study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 when given as monotherapy (Part 1) or given as combination therapy (Part 2). Dose escalation will follow a 3+3 design.
Interventions
DRUGBelantamab mafodotin
Belantamab mafodotin will be administered as an intravenous infusion.
DRUGBortezomib
Bortezomib solution for injection will be administered subcutaneously.
DRUGDexamethasone
Dexamethasone tablets will be administered orally.
DRUGPomalidomide
Pomalidomide capsules will be administered orally.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This will be an open-label study.
Intervention model description
Participants will receive GSK2857916 monotherapy during Part 1 (Dose escalation) of the study on a once every 21 days schedule. During Part 2, participants will receive GSK2857916 given in combination with Bortezomib/Dexamethasone on a once every 21 days schedule (Arm A) or with Pomalidomide/Dexamethasone on a once every 28 days schedule (Arm B).
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Male or female, 20 years or older (at the time consent is obtained). * ECOG performance status of 0 to 2. * Histologically or cytologically confirmed diagnosis of multiple myeloma as defined according to IMWG 2014, criteria in a participant who fulfills all of the following: has undergone stem cell transplant, or is considered transplant ineligible, Part 1: has received at least 2 prior lines of anti-myeloma drugs containing at least 1 proteasome inhibitor and at least 1 immunomodulator, Part 2: has received at least 1 prior line of anti-myeloma drugs; has demonstrated progression on, or within 60 days of completion of the last therapy. * Has measurable disease with at least one of the following: serum M-protein \>=0.5 grams per deciliter (g/dL) (\>=5 grams per liter \[g/L\]); Urine M-protein \>=200 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level \>=10 mg/dL (\>=100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: Transplant was \>100 days prior to study enrolment; No active infection. * Female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breast feeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or For Part 1 and Part 2 Arm A: Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1 percent per year), preferably with low user dependency, during the treatment period and for 4 months after the last dose of GSK2857916, and 7 months from the last dose of bortezomib (only Part 2 Arm A), and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study treatment and agree to use effective contraception during the study and for 4 months after the last dose of GSK2857916, and 7 months from the last dose of bortezomib (only Part 2 Arm A); For Part 2 Arm B: Due to pomalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a restricted distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of pomalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of \<1 percent per year) for a further 3 months, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. Two negative pregnancy tests must be obtained prior to initiating pomalidomide therapy. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to prescribing pomalidomide therapy. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Male participants: Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 6 months after the last dose of GSK2857916, 4 months after the last dose of bortezomib (only Part 2 Arm A), and 4 weeks after the last dose of pomalidomide (only Part 2 Arm B) to allow for clearance of any altered sperm: Refrain from donating sperm plus either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception/barrier as detailed: Agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of \<1 percent per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females). * All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03, must be \<=Grade 1 at the time of enrolment except for alopecia. Participants with Grade 2 peripheral neuropathy can be enrolled into Part 1 and Part 2 Arm B but not into Part 2 Arm A. * Adequate Organ System Function.
Exclusion criteria
* Systemic anti-tumor-therapy within 14 days, or plasmapheresis within 7 days prior to the first dose of study treatment. * Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes' (POEMS) syndrome, active plasma cell leukemia at the time of screening. * Use of an investigational drug within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study treatment. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study treatment. Prior BCMA targeted therapy. * History of an allogeneic stem cell transplant. * Current use of prohibited medications/device or planned use of any of these during the study period. * Current corneal epithelial disease except mild punctate keratopathy * Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from multiple myeloma are eligible, provided they fulfil the required criteria. * Evidence of active mucosal or internal bleeding. * Any major surgery within the last 4 weeks. * Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures. * Active infection requiring treatment (antibiotic, antiviral, or antifungal treatment). * Evidence of severe or uncontrolled systemic diseases. * Malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the investigators and Medical Monitor, will not affect the evaluation of the effects of this clinical study treatment on the currently targeted malignancy (multiple myeloma). * Evidence of cardiovascular risk including any of the following: 1. Corrected QT interval Fridericia (QTcF) interval \>=470 milliseconds (msecs) (the QT interval values must be corrected for heart rate by Fridericia's formula \[QTcF\]) 2. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. 3. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 6 months of Screening. 4. Class III or IV heart failure as defined by the New York Heart Association functional classification system 5. Uncontrolled hypertension * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916 or any of the components of the study treatment. * Pregnant or lactating female or female who are interrupting lactation. * Known human Immunodeficiency virus (HIV) infection. * Presence of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment). * Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. Participants with positive hepatitis C antibody due to prior resolved disease can only be enrolled, if a confirmatory negative hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria. * Previously diagnosed with interstitial lung disease or current complication of interstitial lung disease. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to Day 21 | DLT is an Adverse Event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment for abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03. |
| Part 2: Arm A: Number of Participants With DLTs | Up to Day 21 | DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03. |
| Part 2: Arm B: Number of Participants With DLTs | Up to Day 28 | DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03. |
| Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 141 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. SAEs are subset of AEs. |
| Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 212 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. |
| Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 141 weeks | Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.03. Grade (G)1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 141 weeks | Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 212 weeks | Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to NCI-CTCAE v 4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 212 weeks | Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 141 weeks | Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 141 weeks | Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 212 weeks | Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 212 weeks | Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, MCHC, MCH, MCV, erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes, and increases to high from baseline values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Baseline (Day 1) and up to approximately 141 weeks | Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample. |
| Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Baseline (Day 1) and up to approximately 212 weeks | Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample. |
| Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to approximately 141 weeks | Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Change From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and up to approximately 212 weeks | Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Change From Baseline in Urine Specific Gravity by Dipstick | Baseline (Day 1) and up to approximately 141 weeks | Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Change From Baseline in Urine Specific Gravity by Dipstick | Baseline (Day 1) and up to approximately 212 weeks | Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day 1) and up to approximately 141 weeks | DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day 1) and up to approximately 212 weeks | DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Baseline (Day 1) and up to approximately 141 weeks | Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Baseline (Day 1) and up to approximately 212 weeks | Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Baseline (Day 1) and up to approximately 141 weeks | Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High. |
| Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Baseline (Day 1) and up to approximately 212 weeks | Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High. |
| Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | Baseline (Day 1) and up to approximately 141 weeks | 12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | Baseline (Day 1) and up to approximately 212 weeks | 12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline (Day 1) and up to approximately 141 weeks | The number of participants with worst-case post baseline performance status have been presented as 0-5. Where, 0- Fully active; 1- Restricted in strenuous activity but able to carry out light work activities; 2- Capable of self-care but unable to carry out any work activities; 3- Capable of limited self care, confined to bed/chair more than 50% of waking hours; 4- Completely disabled; can't carry on any self care; totally confined to bed/chair and 5- Dead.Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. |
| Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status | Baseline (Day 1) and up to approximately 212 weeks | Any change in ECOG Performance status that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1. |
| Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1. |
| Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1. |
| Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1. |
| Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1. |
| Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2 Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2 Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC)) | Pre-Dose; End of Infusion (EOI); 1 hour (h), 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Up to approximately 141 weeks | Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin. |
| Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Up to approximately 212 weeks | Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin. |
| Part 1: Titers of ADAs Against Belantamab Mafodotin | Up to approximately 141 weeks | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. |
| Part 2: Titers of ADAs Against Belantamab Mafodotin | Up to approximately 212 weeks | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. |
| Part 1 - Percentage of Participants With Overall Response Rate (ORR) | Up to approximately 141 weeks | ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (i.e. PR, very good partial response \[VGPR\], complete response \[CR\], and stringent complete response \[sCR\]) of best response, according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 hour (h); PR = \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h. |
| Part 2 - Percentage of Participants With ORR | Up to approximately 212 weeks | ORR is defined as the percentage of participants with a confirmed PR or better (i.e. PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200 mg/24 h. |
| Part 1: Clinical Benefit Rate (CBR) | Up to approximately 141 weeks | CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required. |
| Part 2: Clinical Benefit Rate (CBR) | Up to approximately 212 weeks | CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required. |
| Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
| Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. |
Countries
Japan
Participant flow
Pre-assignment details
The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. In PACT phase those participants benefiting from drug continued to receive study drug until discontinuation or withdrawal from study.
Participants by arm
| Arm | Count |
|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | 4 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | 4 |
| Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | 3 |
| Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. | 4 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Main Study: Part 1 (Up to 141 Weeks) | Death | 0 | 1 | 0 | 0 | 0 | 0 |
| Main Study: Part 2 (Up to 212 Weeks) | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Main Study: Part 2 (Up to 212 Weeks) | Progressive disease | 0 | 0 | 0 | 1 | 0 | 0 |
| Main Study: Part 2 (Up to 212 Weeks) | Transitioned to PACT | 0 | 0 | 2 | 2 | 0 | 0 |
| Main Study: Part 2 (Up to 212 Weeks) | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Total |
|---|---|---|---|---|---|
| Age, Customized 20 to 76 years | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian- Japanese Heritage | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 1 / 4 | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 3 / 3 | 4 / 4 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 2 / 4 | 0 / 4 | 0 / 3 | 1 / 4 | 1 / 2 | 0 / 2 |
Outcome results
Primary
Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH)
Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH) | Baseline (Day 1) | 7.13 pH | Standard Deviation 0.75 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH) | CFB to 141 Weeks | -0.75 pH | Standard Deviation 0.645 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH) | Baseline (Day 1) | 5.38 pH | Standard Deviation 0.479 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH) | CFB to 141 Weeks | 0.67 pH | Standard Deviation 1.155 |
Primary
Part 1: Change From Baseline in Urine Specific Gravity by Dipstick
Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Change From Baseline in Urine Specific Gravity by Dipstick | Baseline (Day 1) | 1.0128 Ratio | Standard Deviation 0.00591 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Change From Baseline in Urine Specific Gravity by Dipstick | CFB to 141 Weeks | -0.0010 Ratio | Standard Deviation 0.0101 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Change From Baseline in Urine Specific Gravity by Dipstick | Baseline (Day 1) | 1.0190 Ratio | Standard Deviation 0.00408 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Change From Baseline in Urine Specific Gravity by Dipstick | CFB to 141 Weeks | -0.0037 Ratio | Standard Deviation 0.00451 |
Primary
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. SAEs are subset of AEs.
Time frame: Up to approximately 141 weeks
Population: All Treated Population included all eligible participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT is an Adverse Event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment for abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03.
Time frame: Up to Day 21
Population: DLT Evaluable population included participants fulfilling the 'All Treated' population (all eligible participants who received at least 1 dose of study treatment) criteria, and those who received a complete infusion in 21- day Cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
Primary
Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | Increase to Grade 2 (481 - 500 msec)) | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | Increase to Grade 3 (>= 501 msec)) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | Increase to Grade 2 (481 - 500 msec)) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | Increase to Grade 3 (>= 501 msec)) | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population. Only those participants with data available at specified category have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, No Change/Decreased | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to +- | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to LARGE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 1+ | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 2+ | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to MODERATE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 3+ | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, No Change/Decreased | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Unknown | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to SMALL | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Unknown | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to SMALL | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 1+ | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, No Change/Decreased | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to MODERATE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to LARGE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, No Change/Decreased | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to +- | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 2+ | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 3+ | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population. Participants are counted twice if the participant has values that changed Decreased to Low and Increased to High, so the sum of the percentages may not add to 100% for each category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Change to Normal or No Change | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Increase to High | 1 Participants |
Primary
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
The number of participants with worst-case post baseline performance status have been presented as 0-5. Where, 0- Fully active; 1- Restricted in strenuous activity but able to carry out light work activities; 2- Capable of self-care but unable to carry out any work activities; 3- Capable of limited self care, confined to bed/chair more than 50% of waking hours; 4- Completely disabled; can't carry on any self care; totally confined to bed/chair and 5- Dead.Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 0 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 1 | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 4-5 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 2 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 4-5 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 0 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 1 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 2 | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population. Participants are counted twice if the participant has values that changed Decreased to Low and Increased to High, so the sum of the percentages may not add to 100% for each category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Decrease to Low | 2 Participants |
Primary
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Decrease to Low (<60 bpm) | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Increase to High (>100 bpm) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Decrease to Low (<60 bpm) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Increase to High (>100 bpm) | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Change to Normal or No Change | 3 Participants |
Primary
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Decrease to =<35 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Change to Normal or to No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Increase to >=38 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Decrease to =<35 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Change to Normal or to No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Increase to >=38 | 0 Participants |
Primary
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.03. Grade (G)1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population. Only those participants with data available at specified category have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 3 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Any Grade Increase | 4 Participants |
Primary
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 3 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 4 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 3 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 3 | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 3 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 4 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 4 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 4 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Any Grade Increase | 2 Participants |
Primary
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 141 weeks
Population: All treated population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Any Grade Increase | 2 Participants |
Primary
Part 2: Arm A: Number of Participants With DLTs
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
Time frame: Up to Day 21
Population: DLT Evaluable population included participants fulfilling the 'All Treated' population criteria, and those who received a complete infusion of Belantamab Mafodotin and at least 75% of planned doses of bortezomib/dexamethasone in 21-day Cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: Number of Participants With DLTs | 0 Participants |
Primary
Part 2: Arm B: Number of Participants With DLTs
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
Time frame: Up to Day 28
Population: DLT Evaluable population included participants fulfilling the 'All Treated' population criteria, and those who received a complete infusion of Belantamab Mafodotin and at least 75% of planned doses of pomalidomide/dexamethasone in 28-day Cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: Number of Participants With DLTs | 1 Participants |
Primary
Part 2: Change From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Change From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) | 6.33 pH | Standard Deviation 1.041 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Change From Baseline in Urine Potential of Hydrogen (pH) | CFB to 212 weeks | 0.00 pH | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Change From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) | 5.25 pH | Standard Deviation 0.5 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Change From Baseline in Urine Potential of Hydrogen (pH) | CFB to 212 weeks | 1.50 pH | Standard Deviation 0.707 |
Primary
Part 2: Change From Baseline in Urine Specific Gravity by Dipstick
Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Change From Baseline in Urine Specific Gravity by Dipstick | Baseline (Day 1) | 1.0167 Ratio | Standard Deviation 0.00723 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Change From Baseline in Urine Specific Gravity by Dipstick | CFB to 212 Weeks | -0.0070 Ratio | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Change From Baseline in Urine Specific Gravity by Dipstick | Baseline (Day 1) | 1.0218 Ratio | Standard Deviation 0.00608 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Change From Baseline in Urine Specific Gravity by Dipstick | CFB to 212 Weeks | -0.0055 Ratio | Standard Deviation 0.00354 |
Primary
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs.
Time frame: Up to approximately 212 weeks
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
Primary
Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status
Any change in ECOG Performance status that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status | 0 Participants |
Primary
Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF
12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | Increase to Grade 2 (481 - 500 msec) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | Increase to Grade 3 (>= 501 msec) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | Increase to Grade 2 (481 - 500 msec) | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | Increase to Grade 3 (>= 501 msec) | 0 Participants |
Primary
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population. Only those participants with data available at specified category have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to MODERATE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to +- | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to SMALL | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 1+ | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to LARGE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 2+ | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, No Change/Decreased | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 3+ | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, No Change/Decreased | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Unknown | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, No Change/Decreased | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, No Change/Decreased | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to SMALL | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to MODERATE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Occult Blood, Increase to LARGE | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Unknown | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to +- | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 1+ | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 2+ | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | Protein, Increase to 3+ | 0 Participants |
Primary
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population. Only those participants with data available at specified category have been analyzed. Participants are counted twice if the participant has values that changed Decreased to Low and Increased to High, so the sum of the percentages may not add to 100% for each category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Change to Normal or No Change | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Decrease to Low | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Change to Normal or No Change | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Direct Bilirubin, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Lactate Dehydrogenase, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Chloride, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Protein, Decrease to Low | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Urea, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | C Reactive Protein, Increase to High | 3 Participants |
Primary
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, MCHC, MCH, MCV, erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes, and increases to high from baseline values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population. Participants are counted twice if the participant has values that changed Decreased to Low and Increased to High, so the sum of the percentages may not add to 100% for each category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Change to Normal or No Change | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Increase to High | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Increase to High | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Decrease to Low | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Change to Normal or No Change | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Change to Normal or No Change | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Increase to High | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Decrease to Low | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Change to Normal or No Change | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Increase to High | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Increase to High | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Decrease to Low | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Change to Normal or No Change | 1 Participants |
Primary
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Decrease to Low (<60 bpm) | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Change to Normal or No Change | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Increase to High (>100 bpm) | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Decrease to Low (<60 bpm) | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | Increase to High (>100 bpm) | 0 Participants |
Primary
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Decrease to <=35 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Change to Normal or No Change | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Increase to >=38 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Decrease to <=35 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Change to Normal or No Change | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | Increase to >=38 | 0 Participants |
Primary
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to NCI-CTCAE v 4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population. Only those participants with data available at specified category have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypoglycemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Albumin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | ALP, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | AST, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Bilirubin, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypercalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypocalcemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | CK, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Creatinine, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | GGT, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypermagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypomagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Phosphate, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperkalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypokalemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hypernatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyponatremia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Hyperuricemia, Increase to Grade 3 | 0 Participants |
Primary
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 3 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 4 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Any Grade Increase | 4 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Any Grade Increase | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Any Grade Increase | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelets, Increase to Grade 4 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophils, Increase to Grade 4 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | White blood cell decreased, Increase to Grade 4 | 1 Participants |
Primary
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to approximately 212 weeks
Population: All treated population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Any Grade Increase | 2 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Any Grade Increase | 3 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 1 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 1 Participants |
Secondary
Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 7.373 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 7.779 Day |
Secondary
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; End of Infusion (EOI); 1 hour (h), 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC)) | 3694.5965 Hour*microgram/millilitre (h*ug/mL) | Geometric Coefficient of Variation 26.33 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC)) | 3807.9179 Hour*microgram/millilitre (h*ug/mL) | Geometric Coefficient of Variation 41.8 |
Secondary
Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 6939.1227 h*ug/mL | Geometric Coefficient of Variation 31.13 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 6789.2291 h*ug/mL | Geometric Coefficient of Variation 11.8 |
Secondary
Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 6358.4427 Hour*microgram/millilitre (h*ug/mL) | Geometric Coefficient of Variation 33.08 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 7143.7202 Hour*microgram/millilitre (h*ug/mL) | Geometric Coefficient of Variation 45.6 |
Secondary
Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) | 73.3412 h*ug/mL | Geometric Coefficient of Variation 44.73 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) | 141.9031 h*ug/mL | Geometric Coefficient of Variation 77.03 |
Secondary
Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 5839.2501 h*ug/mL | Geometric Coefficient of Variation 32.96 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 4046.1161 h*ug/mL | Geometric Coefficient of Variation 179.35 |
Secondary
Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 4177.9497 h*ug/mL | Geometric Coefficient of Variation 28.48 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 4243.1678 h*ug/mL | Geometric Coefficient of Variation 48.78 |
Secondary
Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 3606.0173 h*ug/mL | Geometric Coefficient of Variation 22.64 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 2392.2534 h*ug/mL | Geometric Coefficient of Variation 128.99 |
Secondary
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 2 | 195.09 ug/mL | Geometric Coefficient of Variation 12.59 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 6 | 288.80 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 3 | 270.80 ug/mL | Geometric Coefficient of Variation 57.38 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 9 | 222.80 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 1 | 304.99 ug/mL | Geometric Coefficient of Variation 61.67 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 12 | 234.90 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 1 | 330.71 ug/mL | Geometric Coefficient of Variation 23.09 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 2 | 221.76 ug/mL | Geometric Coefficient of Variation 31.09 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 3 | 222.00 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 6 | 205.70 ug/mL | Geometric Coefficient of Variation 13.62 |
Secondary
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 2 | 38.17 ug/mL | Geometric Coefficient of Variation 17.01 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 6 | 32.00 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 3 | 35.56 ug/mL | Geometric Coefficient of Variation 18.19 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 9 | 40.90 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 32.68 ug/mL | Geometric Coefficient of Variation 27.15 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 12 | 36.60 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 45.65 ug/mL | Geometric Coefficient of Variation 8.62 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 2 | 40.97 ug/mL | Geometric Coefficient of Variation 14.9 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 3 | 46.10 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 6 | 39.14 ug/mL | Geometric Coefficient of Variation 19.27 |
Secondary
Part 1: Clinical Benefit Rate (CBR)
CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required.
Time frame: Up to approximately 141 weeks
Population: All treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Clinical Benefit Rate (CBR) | 50 Percentage of Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Clinical Benefit Rate (CBR) | 75 Percentage of Participants |
Secondary
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 2 | 38.17 ug/mL | Geometric Coefficient of Variation 17.01 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 6 | 32.00 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 3 | 35.56 ug/mL | Geometric Coefficient of Variation 18.19 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 9 | 40.90 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 39.51 ug/mL | Geometric Coefficient of Variation 17 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 12 | 36.60 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 48.89 ug/mL | Geometric Coefficient of Variation 14.07 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 2 | 40.97 ug/mL | Geometric Coefficient of Variation 14.9 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 3 | 46.10 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 6 | 39.14 ug/mL | Geometric Coefficient of Variation 19.27 |
Secondary
Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 748.94 ug/mL | Geometric Coefficient of Variation 30.49 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 2797.27 ug/mL | Geometric Coefficient of Variation 326.5 |
Secondary
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 3 | 23.25 ug/mL | Geometric Coefficient of Variation 20.83 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 2 | 32.52 ug/mL | Geometric Coefficient of Variation 14.13 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 6 | 23.60 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 30.28 ug/mL | Geometric Coefficient of Variation 24.32 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 9 | 24.50 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 39.42 ug/mL | Geometric Coefficient of Variation 14.15 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 3 | 32.20 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 12 | 34.50 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 2 | 31.44 ug/mL | Geometric Coefficient of Variation 58.71 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 6 | 29.22 ug/mL | Geometric Coefficient of Variation 24.69 |
Secondary
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | NA ug/mL |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | NA ug/mL |
Secondary
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 4.47 ug/mL | Geometric Coefficient of Variation 22.16 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 2 | 6.34 ug/mL | Geometric Coefficient of Variation 87.45 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 5 | 11.40 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 8 | 18.10 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 11 | 1.37 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 5.19 ug/mL | Geometric Coefficient of Variation 104.06 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 5 | 4.04 ug/mL | Geometric Coefficient of Variation 152.78 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 2 | 6.07 ug/mL | — |
Secondary
Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 0.00319945 1/h | Geometric Coefficient of Variation 23.42 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 0.00310928 1/h | Geometric Coefficient of Variation 31.74 |
Secondary
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 2 | 32.52 ug/mL | Geometric Coefficient of Variation 14.13 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 6 | 23.60 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 3 | 23.25 ug/mL | Geometric Coefficient of Variation 20.83 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 9 | 24.50 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 36.35 ug/mL | Geometric Coefficient of Variation 19.12 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 12 | 34.50 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 41.25 ug/mL | Geometric Coefficient of Variation 12.8 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 2 | 31.44 ug/mL | Geometric Coefficient of Variation 58.71 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 3 | 32.20 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 6 | 29.22 ug/mL | Geometric Coefficient of Variation 24.69 |
Secondary
Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.
Time frame: Up to approximately 141 weeks
Population: All treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
Secondary
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 0.783 Ratio | Geometric Coefficient of Variation 16 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 0.925 Ratio | — |
Secondary
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 0.603 Ratio | Geometric Coefficient of Variation 117 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 0.869 Ratio | — |
Secondary
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Time frame: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 1.139 Ratio | Geometric Coefficient of Variation 26 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 1.075 Ratio | — |
Secondary
Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1.
Time frame: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 1.561 Ratio | Geometric Coefficient of Variation 30 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 1.909 Ratio | — |
Secondary
Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1.
Time frame: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 2.069 Ratio |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 1.775 Ratio |
Secondary
Part 1 - Percentage of Participants With Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (i.e. PR, very good partial response \[VGPR\], complete response \[CR\], and stringent complete response \[sCR\]) of best response, according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 hour (h); PR = \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h.
Time frame: Up to approximately 141 weeks
Population: All treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1 - Percentage of Participants With Overall Response Rate (ORR) | 50 Percentage of Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1 - Percentage of Participants With Overall Response Rate (ORR) | 25 Percentage of Participants |
Secondary
Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 35.026301 milliliter per hour (mL/h) | Geometric Coefficient of Variation 37.38 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 45.340473 milliliter per hour (mL/h) | Geometric Coefficient of Variation 37.25 |
Secondary
Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 22.017014 mL/h | Geometric Coefficient of Variation 34.8 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 25.916718 mL/h | Geometric Coefficient of Variation 25.61 |
Secondary
Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 10.046 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 9.512 Day |
Secondary
Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 0.00385688 1/hour (h) | Geometric Coefficient of Variation 8.96 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 0.00394671 1/hour (h) | Geometric Coefficient of Variation 27.64 |
Secondary
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 21.578 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 21.079 Day |
Secondary
Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 2.600 hour (h) |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 1.635 hour (h) |
Secondary
Part 1: Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Up to approximately 141 weeks
Population: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Secondary
Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 6.940 day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 6.930 day |
Secondary
Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 18.627 day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 21.079 day |
Secondary
Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 16.380 hour (h) |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 16.240 hour (h) |
Secondary
Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 2.695 hour (h) |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 1.675 hour (h) |
Secondary
Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 5 | 3.17 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 2 | 2.41 ug/mL | Geometric Coefficient of Variation 75.3 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 8 | 3.60 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 1.45 ug/mL | Geometric Coefficient of Variation 29.42 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 2 | 1.76 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 1.39 ug/mL | Geometric Coefficient of Variation 109.19 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 5 | 2.20 ug/mL | — |
Secondary
Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 7.475899 Liter (L) | Geometric Coefficient of Variation 29.1 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 8.216505 Liter (L) | Geometric Coefficient of Variation 36.05 |
Secondary
Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 6.390107 Liter (L) | Geometric Coefficient of Variation 18.84 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 6.718238 Liter (L) | Geometric Coefficient of Variation 59.09 |
Secondary
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 46.34 ug/mL | Geometric Coefficient of Variation 27.07 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 4 | 34.80 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 6 | 47.20 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 9 | 35.90 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 10 | 48.20 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 11 | 25.60 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 12 | 37.60 ug/mL | — |
Secondary
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 1 | 319.85 pg/mL | Geometric Coefficient of Variation 29.78 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 4 | 399.10 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 6 | 207.50 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 9 | 88.60 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 10 | 179.00 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 11 | 232.00 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 12 | 336.00 pg/mL | — |
Secondary
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 9 | 43.60 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 10 | 55.70 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 11 | 30.40 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 40.80 ug/mL | Geometric Coefficient of Variation 10.98 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 4 | 40.80 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 6 | 38.20 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 12 | 35.20 ug/mL | — |
Secondary
Part 2 Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Ctrough values were not determined for cycles where the concentration values were below the Lower Limit of Quantification (LLOQ).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 3 | 0.56 ug/mL |
Secondary
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11
Population: Pharmacokinetic population. Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Unknown | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 11 | — pg/mL |
| Unknown | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 3 | — pg/mL |
| Unknown | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 5 | — pg/mL |
| Unknown | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 8 | — pg/mL |
| Unknown | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 9 | — pg/mL |
| Unknown | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Cycle 10 | — pg/mL |
Secondary
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 3 | 2.11 ug/mL |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 5 | 0.84 ug/mL |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 8 | 1.77 ug/mL |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 10 | 1.41 ug/mL |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 11 | 0.74 ug/mL |
Secondary
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 10 | 52.10 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 52.96 ug/mL | Geometric Coefficient of Variation 21.31 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 2 | 34.30 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 4 | 53.90 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 11 | 45.70 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 24 | 32.00 ug/mL | — |
Secondary
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 1 | 390.28 pg/mL | Geometric Coefficient of Variation 46.28 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 2 | 428.60 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 4 | 499.80 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 10 | 198.00 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 11 | 269.00 pg/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | CYCLE 24 | 346.00 pg/mL | — |
Secondary
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 55.85 ug/mL | Geometric Coefficient of Variation 12.63 |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 2 | 42.40 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 4 | 46.30 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 10 | 54.00 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 11 | 71.40 ug/mL | — |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 24 | 34.30 ug/mL | — |
Secondary
Part 2 Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Ctrough values were not determined for cycles where the concentration values were below the Lower Limit of Quantification (LLOQ).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | CYCLE 1 | 1.05 ug/mL |
Secondary
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23
Population: Pharmacokinetic population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | NA pg/mL |
Secondary
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 1 | 4.14 ug/mL |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 9 | 3.09 ug/mL |
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | CYCLE 23 | 0.82 ug/mL |
Secondary
Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 6201.7657 h*ug/mL | Geometric Coefficient of Variation 18.62 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 6178.4350 h*ug/mL | Geometric Coefficient of Variation 30.75 |
Secondary
Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. AUC(0-inf) were not calculated for some participants since there were no sufficient data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 9921.8634 h*ug/mL | Geometric Coefficient of Variation 11.55 |
Secondary
Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 5077.3323 h*ug/mL | Geometric Coefficient of Variation 13.1 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 5489.6508 h*ug/mL | Geometric Coefficient of Variation 25.39 |
Secondary
Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 9213.7145 h*ug/mL | Geometric Coefficient of Variation 6.5 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 9590.8606 h*ug/mL | Geometric Coefficient of Variation 23.71 |
Secondary
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 5160.2733 h*ug/mL | Geometric Coefficient of Variation 10.83 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | 5166.5353 h*ug/mL | Geometric Coefficient of Variation 31.9 |
Secondary
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 80.0859 h*nanogram (ng)/mL | Geometric Coefficient of Variation 22.53 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 82.6253 h*nanogram (ng)/mL | Geometric Coefficient of Variation 42.28 |
Secondary
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 9471.9799 h*ug/mL | Geometric Coefficient of Variation 1.97 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 8495.7663 h*ug/mL | Geometric Coefficient of Variation 36.72 |
Secondary
Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC) | 24.684617 mL/h | Geometric Coefficient of Variation 4.44 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC) | 20.900323 mL/h | Geometric Coefficient of Variation 7.2 |
Secondary
Part 2: Clinical Benefit Rate (CBR)
CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required.
Time frame: Up to approximately 212 weeks
Population: All treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Clinical Benefit Rate (CBR) | 100 Percentage of Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Clinical Benefit Rate (CBR) | 50 Percentage of Participants |
Secondary
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 47.62 ug/mL | Geometric Coefficient of Variation 25.07 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 61.70 ug/mL | Geometric Coefficient of Variation 26.51 |
Secondary
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 857.63 picogram (pg)/mL | Geometric Coefficient of Variation 32.99 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 905.42 picogram (pg)/mL | Geometric Coefficient of Variation 28.37 |
Secondary
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 43.51 ug/mL | Geometric Coefficient of Variation 15.05 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 52.33 ug/mL | Geometric Coefficient of Variation 22.64 |
Secondary
Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC) | 0.00302685 1/h | Geometric Coefficient of Variation 15.54 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC) | 0.00470710 1/h | Geometric Coefficient of Variation 59.7 |
Secondary
Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 0.00159877 1/h | Geometric Coefficient of Variation 22.83 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 0.00305831 1/h | Geometric Coefficient of Variation 45.34 |
Secondary
Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.
Time frame: Up to approximately 212 weeks
Population: All treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
Secondary
Part 2 - Percentage of Participants With ORR
ORR is defined as the percentage of participants with a confirmed PR or better (i.e. PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200 mg/24 h.
Time frame: Up to approximately 212 weeks
Population: All treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2 - Percentage of Participants With ORR | 100 Percentage of Participants |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2 - Percentage of Participants With ORR | 50 Percentage of Participants |
Secondary
Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC) | 8.825 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC) | 6.195 Day |
Secondary
Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 16.172 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 10.392 Day |
Secondary
Part 2: Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Up to approximately 212 weeks
Population: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Secondary
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC) | 21.080 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC) | 27.958 Day |
Secondary
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 6.942 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 6.865 Day |
Secondary
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 21.080 Day |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 27.958 Day |
Secondary
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC) | 0.780 hour (h) |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC) | 1.865 hour (h) |
Secondary
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 22.370 h |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 22.950 h |
Secondary
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 1.850 hour (h) |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 1.900 hour (h) |
Secondary
Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC) | 6.801065 Liter (L) | Geometric Coefficient of Variation 4.67 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC) | 4.537404 Liter (L) | Geometric Coefficient of Variation 22.01 |
Secondary
Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)
Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Vss was not calculated for some participants as sufficient data was not available.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | 4.367635 Liter (L) | Geometric Coefficient of Variation 9.29 |