Relapsed/Refractory Multiple Myeloma
Conditions
Brief summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the cohort expansion phase. This study is a sub study of the Master protocol (NCT04126200).
Interventions
DRUGBelantamab Mafodotin
Belantamab Mafodotin will be administered.
DRUGDostarlimab
Dostarlimab will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be 18 years of age inclusive or older, at the time of signing the informed consent. * Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG. * Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody. * Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was \>100 days prior to study enrolment and with no active infection(s). * Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (\<=)2 is due solely to skeletal complications and/or skeletal pain due to MM. * Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (\>=)0.5 gram per deciliter (\>=5 gram per liter) or Urine M-protein \>=200 milligrams (mg) per 24 hours or Serum free light chain (FLC) assay: Involved FLC level \>=10 mg per deciliter (\>=100 mg per Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during screening. * Participants who are currently receiving physiological doses oral steroids (\<10 mg/day), inhaled steroids or ophthalmological steroids.
Exclusion criteria
* Participants with current corneal epithelial disease except mild punctate keratopathy. * Participants with evidence of cardiovascular risk. * Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb. * Participants with active infection requiring antibiotic, antiviral, or antifungal treatment. * Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within \<14 days. * Participants with prior radiotherapy within 2 weeks of start of study therapy. * Participants with prior allogeneic transplant are prohibited. * Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening. * Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days. * Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter. * Participants with \>=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation. * Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug. * Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment. * Participants with 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 MM. * Participants with known human immunodeficiency virus (HIV) infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load\<400 copies/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts \>= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only. * Participants with autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. * Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis. * Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). * Participants who have received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent. * Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DE Phase: Number of Participants With Dose Limiting Toxicities (DLT) | Up to 21 days | Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLTs. Severity was graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (version 5.0). |
| DE Phase: Number of Participants With Adverse Events (AEs) | Up to 153 weeks | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
| DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Baseline (Day 1) and up to 153 weeks | Blood samples were collected for the analysis of following hematology parameters: eosinophils, anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, leukocytosis and white blood cell decreased. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. |
| DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Baseline (Day 1) and up to 153 weeks | Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and chronic kidney disease. G1: mild; G2: moderate; G3: severe. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented. The laboratory parameters were graded according to CTCAE version 5. |
| CE Phase: Overall Response Rate (ORR) | Up to 26 weeks | Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed PR or better as the best overall response (i.e., Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR defined as 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 defined as 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 defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | Predose, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks) | Blood samples were collected for PK analysis of belantamab mafodotin total antibody when administered intravenously in combination with dostarlimab. |
| DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | Predose, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks) | Blood samples were collected for PK analysis of belantamab mafodotin cys-mcMMAF when administered intravenously in combination with dostarlimab. |
| CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) | Up to 153 weeks | Blood samples were to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC). |
| CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody | Up to 153 weeks | Blood samples were to be collected for PK analysis of Belantamab mafodotin plasma total antibody. |
| CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Up to 153 weeks | Blood samples were to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) |
| DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | Predose and end of infusion (EOI) on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, and at the end of treatment (approximately 153 weeks) | Blood samples were collected for PK analysis of dostarlimab when administered intravenously in combination with belantamab mafodotin. |
| CE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | Up to 153 weeks | Blood samples were to be collected for PK analysis of dostarlimab when administered intravenously in combination with belantamab mafodotin. |
| DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Up to 153 weeks | Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. |
| CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin | Up to 153 weeks | Serum samples were to be 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. |
| DE Phase: Number of Participants With Post-baseline Positive ADAs Against Dostarlimab | Up to 153 weeks | Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. |
| CE Phase: Number of Participants With Post-baseline Positive ADAs Against Dostarlimab | Up to 153 weeks | Serum samples were to be 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. |
| DE Phase: Concentration of ADAs Against Dostarlimab When Administered in Combination With Belantamab Mafodotin | Up to 153 weeks | Serum samples were 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. |
| CE Phase: Concentration of ADAs Against Dostarlimab When Administered in Combination With Belantamab Mafodotin | Up to 153 weeks | Serum samples were to be 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. |
| DE Phase: Concentration of ADAs Against Belantamab Mafodotin | Up to 153 weeks | Serum samples were 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. |
| DE Phase: Overall Response Rate (ORR) | Up to 153 weeks | Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed PR or better as the best overall response (i.e., Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR defined as 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 defined as 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 defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. |
| DE Phase: Number of Participants With Adverse Events of Special Interest (AESI) | Up to 153 weeks | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events of special interest (AESIs) were collected. |
| CE Phase: Number of Participants With Adverse Events of Special Interest (AESI) | Up to 153 weeks | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events of special interest (AESIs) were to be collected. |
| DE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade | Up to 153 weeks | The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade. |
| CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade | Up to 153 weeks | The corneal events were to be graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Corneal Events were to be examined. |
| CE Phase: Progression-free Survival (PFS) | Up to 153 weeks | PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause. |
| CE Phase: Duration of Response (DoR) | Up to 153 weeks | DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better. |
| CE Phase: Time to Response (TTR) | Up to 153 weeks | TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better). |
| CE Phase: Overall Survival (OS) | Up to 153 weeks | OS is defined as the time from randomization until death due to any cause. |
| CE Phase: Number of Participants With AEs and SAEs | Up to 153 weeks | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. |
| CE Phase: Number of Participants With AEs Leading to Discontinuation | Up to 153 weeks | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to discontinuation were to be evaluated. |
| CE Phase: Number of Participants With Dose Reduction or Delay | Up to 153 weeks | Number of participants with dose reduction or delay were to be evaluated. |
| CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters | Up to 153 weeks | Blood samples were to be collected for the analysis of following hematology parameters: eosinophils, anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, leukocytosis and white blood cell decreased. The laboratory parameters were to be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. |
| CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters | Up to 153 weeks | Blood samples were to be collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and chronic kidney disease. The laboratory parameters were to be graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. |
| CE Phase: Concentration of ADAs Against Belantamab Mafodotin | Up to 153 weeks | Serum samples were to be 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. |
| CE Phase: Clinical Benefit Rate (CBR) | Up to 153 weeks | Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%. |
| DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Up to 153 weeks | Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR defined as 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 defined as 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 defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. |
| CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR | Up to 153 weeks | Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, 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 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. |
| DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | Predose, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks) | Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC) when administered intravenously in combination with dostarlimab. |
Countries
France, South Korea
Participant flow
Recruitment details
This is a sub study of the master study NCT04126200. This sub study was terminated due to lack of efficacy. The study was planned to include two phases - Dose Escalation (DE) and Cohort Expansion (CE) and no participants from this sub study were enrolled in CE phase as study was early terminated.
Participants by arm
| Arm | Count |
|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W). | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab |
|---|---|
| Age, Continuous | 70.0 YEAR STANDARD_DEVIATION 9.83 |
| Race/Ethnicity, Customized Others | 4 Participants |
| Sex/Gender, Customized Males and Females | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 2 / 4 |
Outcome results
Primary
CE Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed PR or better as the best overall response (i.e., Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR defined as 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 defined as 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 defined as ≥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 26 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Primary
DE Phase: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to 153 weeks
Population: Safety population included all participants who received at least 1 dose of any component of the combination therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Adverse Events (AEs) | 4 Participants |
Primary
DE Phase: Number of Participants With Dose Limiting Toxicities (DLT)
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLTs. Severity was graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (version 5.0).
Time frame: Up to 21 days
Population: DLT Evaluable Population included participants in DE who have received the first course of treatment containing both agents within a sub-study and followed up within cycle 1 (Each cycle is of 21 days) or withdrew within cycle 1 due to an AE meeting the definition of a DLT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Dose Limiting Toxicities (DLT) | 1 Participants |
Primary
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and chronic kidney disease. G1: mild; G2: moderate; G3: severe. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented. The laboratory parameters were graded according to CTCAE version 5.
Time frame: Baseline (Day 1) and up to 153 weeks
Population: Safety Population. Only those participants with data available at the specified categories were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypernatremia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypernatremia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypernatremia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypercalcemia, Increase to Grade 1 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypercalcemia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypercalcemia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypocalcemia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypocalcemia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypocalcemia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypoglycemia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypoglycemia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypoglycemia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grade 2 | 2 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grade 1 | 2 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grade 2 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grade 1 | 2 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grade 3 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grade 2 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | CPK increased, Increase to Grade 1 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | CPK increased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | CPK increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Creatinine increased, Increase to Grade 1 | 2 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Creatinine increased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Creatinine increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | GGT increased, Increase to Grade 1 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | GGT increased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | GGT increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hyperkalemia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hyperkalemia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hyperkalemia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grade 1 | 4 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypermagnesemia, Increase to Grade 1 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypermagnesemia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypermagnesemia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypomagnesemia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypomagnesemia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hypomagnesemia, Increase to Grade 3 | 0 Participants |
Primary
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for the analysis of following hematology parameters: eosinophils, anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, leukocytosis and white blood cell decreased. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time frame: Baseline (Day 1) and up to 153 weeks
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Anemia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Anemia, Increase to Grade 2 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Anemia, Increase to Grade 3 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Anemia, Increase to Grade 4 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hemoglobin increased, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hemoglobin increased, Increase to Grade 2 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grade 3 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grade 4 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grade 4 | 2 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grade 2 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grade 2 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Eosinophilia, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Eosinophilia, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Eosinophilia, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Eosinophilia, Increase to Grade 4 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Platelet count decreased, Increase to Grade 1 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Platelet count decreased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Platelet count decreased, Increase to Grade 3 | 2 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Platelet count decreased, Increase to Grade 4 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Leukocytosis, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Leukocytosis, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Leukocytosis, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Leukocytosis, Increase to Grade 4 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | White blood cell decreased, Increase to Grade 1 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | White blood cell decreased, Increase to Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | White blood cell decreased, Increase to Grade 3 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | White blood cell decreased, Increase to Grade 4 | 1 Participants |
Secondary
CE Phase: Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Concentration of ADAs Against Belantamab Mafodotin
Serum samples were to be 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 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Concentration of ADAs Against Dostarlimab When Administered in Combination With Belantamab Mafodotin
Serum samples were to be 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 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin
Blood samples were to be collected for PK analysis of dostarlimab when administered intravenously in combination with belantamab mafodotin.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Duration of Response (DoR)
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With Adverse Events of Special Interest (AESI)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events of special interest (AESIs) were to be collected.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With AEs and SAEs
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With AEs Leading to Discontinuation
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to discontinuation were to be evaluated.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade
The corneal events were to be graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Corneal Events were to be examined.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters
Blood samples were to be collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and chronic kidney disease. The laboratory parameters were to be graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters
Blood samples were to be collected for the analysis of following hematology parameters: eosinophils, anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, leukocytosis and white blood cell decreased. The laboratory parameters were to be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With Dose Reduction or Delay
Number of participants with dose reduction or delay were to be evaluated.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Serum samples were to be 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 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Dostarlimab
Serum samples were to be 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 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, 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 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 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody
Blood samples were to be collected for PK analysis of Belantamab mafodotin plasma total antibody.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Blood samples were to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC).
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Blood samples were to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Progression-free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
CE Phase: Time to Response (TTR)
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
Time frame: Up to 153 weeks
Population: No participants were enrolled in CE Phase as study was terminated.
Secondary
DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC)
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC) when administered intravenously in combination with dostarlimab.
Time frame: Predose, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks)
Population: Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 1 DAY 1, PRE-DOSE | 0.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 1 DAY 1, END OF INFUSION | 25300.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 1 DAY 1, 2 HOURS | 26450.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 1 DAY 1, 24 HOURS | 20400.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 1 DAY 4 | 9110.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 1 DAY 8 | 4830.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 1 DAY 22 | 0.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 2 DAY 1, PRE-DOSE | 1295.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 2 DAY 1, END OF INFUSION | 41950.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 4 DAY 1, PRE-DOSE | 0.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | CYCLE 4 DAY 1, END OF INFUSION | 27600.0 Nanogram/ millilitre (ng/mL) |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC) | END OF TREATMENT | 0.0 Nanogram/ millilitre (ng/mL) |
Secondary
DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF
Blood samples were collected for PK analysis of belantamab mafodotin cys-mcMMAF when administered intravenously in combination with dostarlimab.
Time frame: Predose, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks)
Population: Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 1 DAY 1, PRE-DOSE | 0.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 1 DAY 1, END OF INFUSION | 218.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 1 DAY 1, 2 HOURS | 376.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 1 DAY 1, 24 HOURS | 750.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 1 DAY 4 | 549.50 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 1 DAY 8 | 170.90 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 1 DAY 22 | 0.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 2 DAY 1, PRE-DOSE | 0.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 2 DAY 1, END OF INFUSION | 555.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 4 DAY 1, PRE-DOSE | 0.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | CYCLE 4 DAY 1, END OF INFUSION | 469.00 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF | END OF TREATMENT | 0.00 ng/mL |
Secondary
DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody
Blood samples were collected for PK analysis of belantamab mafodotin total antibody when administered intravenously in combination with dostarlimab.
Time frame: Predose, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks)
Population: Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 1 DAY 1, PRE-DOSE | 0.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 1 DAY 1, END OF INFUSION | 31000.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 1 DAY 1, 2 HOURS | 32400.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 1 DAY 1, 24 HOURS | 21400.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 1 DAY 4 | 15000.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 1 DAY 8 | 8235.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 1 DAY 22 | 1140.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 2 DAY 1, PRE-DOSE | 3625.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 2 DAY 1, END OF INFUSION | 45350.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 4 DAY 1, PRE-DOSE | 2800.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | CYCLE 4 DAY 1, END OF INFUSION | 48900.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody | END OF TREATMENT | 628.0 ng/mL |
Secondary
DE Phase: Concentration of ADAs Against Belantamab Mafodotin
Serum samples were 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 153 weeks
Population: Safety Population. Only those participants with positive post-baseline antibody against belantamab mafodotin were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Concentration of ADAs Against Belantamab Mafodotin | NA ng/mL |
Secondary
DE Phase: Concentration of ADAs Against Dostarlimab When Administered in Combination With Belantamab Mafodotin
Serum samples were 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 153 weeks
Population: Safety Population. No participants were found positive for ADAs, hence participants were not analyzed for concentration of ADAs.
Secondary
DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin
Blood samples were collected for PK analysis of dostarlimab when administered intravenously in combination with belantamab mafodotin.
Time frame: Predose and end of infusion (EOI) on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, and at the end of treatment (approximately 153 weeks)
Population: Pharmacokinetic population included all participants in the Safety population who had at least 1 non-missing PK assessment. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | CYCLE 1 DAY 1, PRE-DOSE | 0.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | CYCLE 1 DAY 1, END OF INFUSION | 52500.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | CYCLE 2 DAY 1, PRE-DOSE | 43550.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | CYCLE 2 DAY 1, END OF INFUSION | 224000.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | CYCLE 5 DAY 1, PRE-DOSE | 532.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | CYCLE 5 DAY 1, END OF INFUSION | 312000.0 ng/mL |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin | END OF TREATMENT | 35750.0 ng/mL |
Secondary
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events of special interest (AESIs) were collected.
Time frame: Up to 153 weeks
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Adverse Events of Special Interest (AESI) | 3 Participants |
Secondary
DE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade.
Time frame: Up to 153 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade | Grade 1 | 1 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade | Grade 2 | 0 Participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade | Grade 3 | 0 Participants |
Secondary
DE Phase: Number of Participants With Post-baseline Positive ADAs Against Dostarlimab
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Time frame: Up to 153 weeks
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Post-baseline Positive ADAs Against Dostarlimab | 0 Participants |
Secondary
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Time frame: Up to 153 weeks
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 1 Participants |
Secondary
DE Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed PR or better as the best overall response (i.e., Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR defined as 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 defined as 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 defined as ≥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 153 weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Overall Response Rate (ORR) | 25 Percentage of participants |
Secondary
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR defined as 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 defined as 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 defined as ≥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 153 weeks
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Stringent Complete Response (sCR) | 0 Percentage of participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Complete Response (CR) | 0 Percentage of participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Very Good Partial Response (VGPR) | 25 Percentage of participants |
| 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab | DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Partial Response (PR) | 0 Percentage of participants |