Multiple Myeloma
Conditions
Keywords
Antibody drug conjugate, Belantamab mafodotin, BLENREP, DREAMM14, GSK2857916, Alternative dosing, Relapsed or refractory multiple myeloma, RRMM
Brief summary
This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.
Interventions
DRUGBelantamab mafodotin
Belantamab mafodotin will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
It is an open label study
Intervention model description
Belantamab mafodotin will be administered using various dosing regimens.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib). * France specific: participants have failed at least 4 prior lines of anti-myeloma therapies * Participant has measurable disease per modified IMWG criteria. * Life expectancy of at least 6 months, in the opinion of the investigator. * Male and female participants agree to abide by protocol-defined contraceptive requirements. * Participant is capable of giving signed informed consent. * Participant meets country-specific inclusion criteria described in the protocol.
Exclusion criteria
* Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening. * Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK). * Evidence of active mucosal or internal bleeding. * Presence of an active renal condition. * Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures. * Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for \>2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. * Evidence of cardiovascular risk as per the protocol criteria. * Pregnant or lactating female. * Active infection requiring antibiotic, antiviral, or antifungal treatment. * Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met. * Hepatitis B and C will be excluded unless the criteria in protocol can be met. * Cirrhosis or current unstable liver or biliary disease. * Alanine aminotransferase (ALT) \>2.5× upper limit of normal (ULN). * Total Bilirubin \>1.5×ULN. * Systemic anti-MM therapy within \<=14 days or 5 half-lives, whichever is shorter. * Systemic therapy with high dose steroids within \<=14 days before the first dose of study treatment. * Prior allogenic stem cell transplant. * Prior treatment with a monoclonal antibody \<=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted. * Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment. * Treatment with an antibody-drug conjugate. * Participant has received any major surgery \<=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery. * Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count \<1.0×10\^9/L, b. Hemoglobin \<8 gram/deciliter (g/dL), c. Platelet count \<50×10\^9/L, d. Spot urine (albumin/creatinine ratio) \>500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2). * UK specific: a. Absolute neutrophil count \<1.5×10\^9/L, c. Platelet count \<75×10\^9/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale | Up to 29.5 months | The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Corneal Events up to Week 16 | Up to week 16 | The number of participants with corneal events were assessed using KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events. |
| Incidence Rate of Corneal Events by Grade (KVA Scale) | Up to 152 weeks | Incidence rate of corneal events is defined as the percentage of participants with corneal events by grade according to the KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events. |
| Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Up to 152 weeks | Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented. |
| Median Duration of All the Dose Delays | Up to 152 weeks | Median duration of dose delays is defined as the median duration in time of all the dose delays in the respective treatment group. Duration of delays is defined as period from the expected start date of dose to actual start date of current dose. |
| Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Up to 152 weeks | The percentage of participants that required dose reduction, dose interruption/delay, permanent treatment discontinuation due to corneal events were evaluated using KVA Scale. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events. |
| Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 3 months, 6 months, 9 months and 12 months | Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events. |
| Toxicity Index (TI) | Up to 152 weeks | Toxicity Index is a composite score derived from the severity grades of adverse events (AEs) reported during the study, based on the Common Terminology Criteria for Adverse Events (CTCAE). A participant's score is calculated as a function of the ordered toxicity grades, represented in descending order by sequence, on a scale of 0-6, where 0 represents no toxicity and 6 represents the highest toxicity. CTCAE grades are defined as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences), and Grade 5 (Death related to AE). Higher grades indicate greater toxicity severity. |
| Duration of Corneal Events of Grade 2 or Above | Up to 152 weeks | Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence. |
| Percentage of Time on Study With Grade 2 or Above Corneal Events | Up to 152 weeks | It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below. |
| Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Baseline (Day 1) and up to 152 weeks | Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.1; a possible worsened vision is defined as a change from baseline \>=0.1 to \<=0.3; a definite worsened vision is defined as a change from baseline \>0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline. |
| Objective Response Rate (ORR) | Up to 152 weeks | ORR was 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 \[sCR\]), 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=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. |
| Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR) | Up to 152 weeks | Percentage of participants with a confirmed VGPR or better defined as percentage of participant with confirmed VGPR, CR, and sCR, according to the 2016 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=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. |
| Time to Response (TTR) | Up to 152 weeks | TTR 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 (i.e., confirmed PR or better), according to the 2016 IMWG response criteria. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. |
| Duration of Response (DoR) | Up to 152 weeks | DoR defined as the time from first documented evidence of PR or better until disease progression (PD) among responders according to the 2016 IMWG response criteria or death due to any cause. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). |
| Time to Progression (TTP) | Up to 152 weeks | TTP defined as the time from randomization until the earliest date of documented PD or death due to PD, according to the 2016 IMWG response criteria. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). |
| Progression Free Survival (PFS) | Up to 152 weeks | PFS defined as the time from randomization until the earliest date of documented PD, according to the 2016 IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). |
| Overall Survival (OS) | Up to 152 weeks | OS defined as the time from randomization until the date of death due to any cause. |
| Percentage of Participants With AEs | Up to 152 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. AEs were coded using the standard Medical Dictionary for Regulatory Activities (MedDRA). |
| Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Up to 152 weeks | Percentage of participants requiring dose reduction, dose interruption/delay, permanent treatment discontinuation due to any AEs were presented. 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. AEs were coded using the standard MedDRA. |
| Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to 152 weeks | Blood samples were collected for the analysis of hematology parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented. |
| Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to 152 weeks | Blood samples were collected for the analysis of clinical chemistry parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented. |
| Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Baseline (Day 1) and up to 152 weeks | Serum samples 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Titers of ADAs Against Belantamab Mafodotin | Up to 152 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. |
| Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15 | Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC). |
| Concentration at 21 Days for Belantamab Mafodotin ADC | At 21 days | Plasma samples were collected for PK analysis for belantamab mafodotin ADC. |
| Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC | C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21 | Plasma samples were collected for PK analysis for belantamab mafodotin ADC. |
| Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC | C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21 | Plasma samples were collected to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin ADC. |
| Half-life (t1/2) of Belantamab Mafodotin ADC | C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15 | Plasma samples were collected for PK analysis of Belantamab mafodotin ADC |
| Clearance (CL) for Belantamab Mafodotin ADC | C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15 | Plasma samples were collected for PK analysis for belantamab mafodotin ADC. |
| Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC | C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15 | Plasma samples were collected for PK analysis for belantamab mafodotin ADC. |
Countries
Argentina, Australia, Brazil, Canada, France, Germany, Greece, Ireland, Italy, Mexico, Poland, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Participant flow
Pre-assignment details
The results presented are based on the data cut-off date of 30 Jan 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death. | 40 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. | 40 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. | 40 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. | 40 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity. | 17 |
| Total | 177 |
Baseline characteristics
| Characteristic | Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 66.6 YEARS STANDARD_DEVIATION 10.36 | 63.0 YEARS STANDARD_DEVIATION 9.02 | 63.7 YEARS STANDARD_DEVIATION 9.92 | 65.4 YEARS STANDARD_DEVIATION 8.87 | 67.1 YEARS STANDARD_DEVIATION 10.42 | 64.9 YEARS STANDARD_DEVIATION 9.66 |
| Race/Ethnicity, Customized Hispanic or Latino | 13 Participants | 9 Participants | 12 Participants | 6 Participants | 6 Participants | 46 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 27 Participants | 31 Participants | 28 Participants | 34 Participants | 11 Participants | 131 Participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 19 Participants | 16 Participants | 8 Participants | 83 Participants |
| Sex: Female, Male Male | 21 Participants | 19 Participants | 21 Participants | 24 Participants | 9 Participants | 94 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 40 | 23 / 40 | 25 / 40 | 21 / 40 | 5 / 17 |
| other Total, other adverse events | 38 / 39 | 36 / 40 | 36 / 39 | 40 / 40 | 16 / 17 |
| serious Total, serious adverse events | 17 / 39 | 17 / 40 | 21 / 39 | 16 / 40 | 4 / 17 |
Outcome results
Primary
Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale
The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
Time frame: Up to 29.5 months
Population: Safety Population included all randomized participants who received at least 1 dose of study treatment. As outlined in the protocol, the objective was to examine the corneal events in Arms B to D, compared to Arm A; hence, Arm E was not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale | 64 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale | 40 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale | 44 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale | 38 Percentage of participants |
Secondary
Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC
Plasma samples were collected to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin ADC.
Time frame: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21
Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC | 4233 micrograms* hour/ millilitre (ug*h/mL) | Geometric Coefficient of Variation 32.2 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC | 3013 micrograms* hour/ millilitre (ug*h/mL) | Geometric Coefficient of Variation 34.6 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC | 3886 micrograms* hour/ millilitre (ug*h/mL) | Geometric Coefficient of Variation 38.6 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC | 3173 micrograms* hour/ millilitre (ug*h/mL) | Geometric Coefficient of Variation 27.1 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC | 3079 micrograms* hour/ millilitre (ug*h/mL) | Geometric Coefficient of Variation 40.6 |
Secondary
Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Time frame: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21
Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC | 8.4 ug/mL | Geometric Coefficient of Variation 32.2 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC | 5.98 ug/mL | Geometric Coefficient of Variation 34.6 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC | 7.71 ug/mL | Geometric Coefficient of Variation 38.6 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC | 6.3 ug/mL | Geometric Coefficient of Variation 27.1 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC | 6.11 ug/mL | Geometric Coefficient of Variation 40.6 |
Secondary
Clearance (CL) for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Time frame: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15
Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Clearance (CL) for Belantamab Mafodotin ADC | 0.8 Liter/ days | Geometric Coefficient of Variation 38.3 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Clearance (CL) for Belantamab Mafodotin ADC | 0.83 Liter/ days | Geometric Coefficient of Variation 57.1 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Clearance (CL) for Belantamab Mafodotin ADC | 0.84 Liter/ days | Geometric Coefficient of Variation 47.7 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Clearance (CL) for Belantamab Mafodotin ADC | 0.74 Liter/ days | Geometric Coefficient of Variation 53.3 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Clearance (CL) for Belantamab Mafodotin ADC | 0.86 Liter/ days | Geometric Coefficient of Variation 59.7 |
Secondary
Concentration at 21 Days for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Time frame: At 21 days
Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Concentration at 21 Days for Belantamab Mafodotin ADC | 2.28 ug/mL | Geometric Coefficient of Variation 56.7 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Concentration at 21 Days for Belantamab Mafodotin ADC | 1.5 ug/mL | Geometric Coefficient of Variation 62.4 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Concentration at 21 Days for Belantamab Mafodotin ADC | 1.94 ug/mL | Geometric Coefficient of Variation 69.3 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Concentration at 21 Days for Belantamab Mafodotin ADC | 1.69 ug/mL | Geometric Coefficient of Variation 50.2 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Concentration at 21 Days for Belantamab Mafodotin ADC | 1.53 ug/mL | Geometric Coefficient of Variation 62.1 |
Secondary
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)
Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
Time frame: At 3 months, 6 months, 9 months and 12 months
Population: Safety Population. Only those participants who experienced corneal events (KVA scale) of Grade 2 or above have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 12 months | 64 Percentage of events |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 9 months | 64 Percentage of events |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 6 months | 64 Percentage of events |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 3 months | 59 Percentage of events |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 3 months | 32 Percentage of events |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 12 months | 40 Percentage of events |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 9 months | 40 Percentage of events |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 6 months | 37 Percentage of events |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 12 months | 44 Percentage of events |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 9 months | 41 Percentage of events |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 6 months | 41 Percentage of events |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 3 months | 36 Percentage of events |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 12 months | 38 Percentage of events |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 3 months | 33 Percentage of events |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 9 months | 38 Percentage of events |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 6 months | 38 Percentage of events |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 6 months | 59 Percentage of events |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 12 months | 59 Percentage of events |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 9 months | 59 Percentage of events |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) | At 3 months | 53 Percentage of events |
Secondary
Duration of Corneal Events of Grade 2 or Above
Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence.
Time frame: Up to 152 weeks
Population: Safety Population. Only those participants who experienced corneal events (KVA Scale) of Grade 2 or above have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Duration of Corneal Events of Grade 2 or Above | 63.0 Days |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Duration of Corneal Events of Grade 2 or Above | 67.5 Days |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Duration of Corneal Events of Grade 2 or Above | 46.5 Days |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Duration of Corneal Events of Grade 2 or Above | 53.5 Days |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Duration of Corneal Events of Grade 2 or Above | 44.0 Days |
Secondary
Duration of Response (DoR)
DoR defined as the time from first documented evidence of PR or better until disease progression (PD) among responders according to the 2016 IMWG response criteria or death due to any cause. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
Time frame: Up to 152 weeks
Population: Intent-to-Treat Population. Only those participants with confirmed PR or better (i.e., PR, VGPR, CR and sCR) have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Duration of Response (DoR) | 15.9 Months |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Duration of Response (DoR) | 22.1 Months |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Duration of Response (DoR) | 6.2 Months |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Duration of Response (DoR) | 7.8 Months |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Duration of Response (DoR) | 15.9 Months |
Secondary
Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade
Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented.
Time frame: Up to 152 weeks
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 3 | 4 Events per 100 patient years |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 5 | 0 Events per 100 patient years |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 4 | 0 Events per 100 patient years |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 4 | 0 Events per 100 patient years |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 3 | 2 Events per 100 patient years |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 5 | 0 Events per 100 patient years |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 4 | 0 Events per 100 patient years |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 3 | 4 Events per 100 patient years |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 5 | 0 Events per 100 patient years |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 3 | 0 Events per 100 patient years |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 5 | 0 Events per 100 patient years |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 4 | 0 Events per 100 patient years |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 4 | 0 Events per 100 patient years |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 3 | 3 Events per 100 patient years |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade | Grade 5 | 0 Events per 100 patient years |
Secondary
Half-life (t1/2) of Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis of Belantamab mafodotin ADC
Time frame: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15
Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Half-life (t1/2) of Belantamab Mafodotin ADC | 13 Days | Geometric Coefficient of Variation 30.5 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Half-life (t1/2) of Belantamab Mafodotin ADC | 12 Days | Geometric Coefficient of Variation 32.1 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Half-life (t1/2) of Belantamab Mafodotin ADC | 12 Days | Geometric Coefficient of Variation 40 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Half-life (t1/2) of Belantamab Mafodotin ADC | 12 Days | Geometric Coefficient of Variation 34.2 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Half-life (t1/2) of Belantamab Mafodotin ADC | 13 Days | Geometric Coefficient of Variation 41.3 |
Secondary
Incidence Rate of Corneal Events by Grade (KVA Scale)
Incidence rate of corneal events is defined as the percentage of participants with corneal events by grade according to the KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
Time frame: Up to 152 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 1 | 3 Percentage of participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 2 | 10 Percentage of participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 3 | 15 Percentage of participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 4 | 0 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 1 | 10 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 4 | 3 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 2 | 4 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 3 | 9 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 4 | 1 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 2 | 5 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 3 | 11 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 1 | 7 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 1 | 10 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 2 | 6 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 4 | 0 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 3 | 9 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 4 | 2 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 3 | 6 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 2 | 3 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Incidence Rate of Corneal Events by Grade (KVA Scale) | Grade 1 | 2 Percentage of participants |
Secondary
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).
Time frame: Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15
Population: Pharmacokinetic (PK) Population included all participants in the Safety Population from whom at least 1 post-treatment PK sample was obtained and analyzed. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC) | 44.8 Microgram/ millilitre (ug/mL) | Geometric Coefficient of Variation 22.8 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC) | 33.1 Microgram/ millilitre (ug/mL) | Geometric Coefficient of Variation 23.2 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC) | 42.1 Microgram/ millilitre (ug/mL) | Geometric Coefficient of Variation 24.7 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC) | 33.1 Microgram/ millilitre (ug/mL) | Geometric Coefficient of Variation 18.3 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC) | 34.1 Microgram/ millilitre (ug/mL) | Geometric Coefficient of Variation 26.8 |
Secondary
Median Duration of All the Dose Delays
Median duration of dose delays is defined as the median duration in time of all the dose delays in the respective treatment group. Duration of delays is defined as period from the expected start date of dose to actual start date of current dose.
Time frame: Up to 152 weeks
Population: Safety Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Median Duration of All the Dose Delays | 39.0 Days |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Median Duration of All the Dose Delays | 18.0 Days |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Median Duration of All the Dose Delays | 51.0 Days |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Median Duration of All the Dose Delays | 60.0 Days |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Median Duration of All the Dose Delays | 59.0 Days |
Secondary
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores
Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.1; a possible worsened vision is defined as a change from baseline \>=0.1 to \<=0.3; a definite worsened vision is defined as a change from baseline \>0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline.
Time frame: Baseline (Day 1) and up to 152 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | No change | 16 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Possible worsened vision | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Definite worsened vision | 4 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | No change | 16 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Possible worsened vision | 4 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Definite worsened vision | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Possible worsened vision | 5 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Definite worsened vision | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | No change | 20 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Definite worsened vision | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | No change | 18 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Possible worsened vision | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | No change | 21 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Possible worsened vision | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | No change | 19 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Definite worsened vision | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Possible worsened vision | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Definite worsened vision | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | No change | 27 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Possible worsened vision | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Definite worsened vision | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Definite worsened vision | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Possible worsened vision | 2 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | No change | 27 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Possible worsened vision | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Definite worsened vision | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | Possible worsened vision | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | Definite worsened vision | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye | No change | 10 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye | No change | 8 Participants |
Secondary
Number of Participants With Corneal Events up to Week 16
The number of participants with corneal events were assessed using KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
Time frame: Up to week 16
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Corneal Events up to Week 16 | 26 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Corneal Events up to Week 16 | 25 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Corneal Events up to Week 16 | 23 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Corneal Events up to Week 16 | 24 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Corneal Events up to Week 16 | 12 Participants |
Secondary
Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples 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. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and up to 152 weeks
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 0 Participants |
Secondary
Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of clinical chemistry parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.
Time frame: Up to 152 weeks
Population: Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 1 to 4 | 4 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 2 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 1 to 4 | 19 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 2 to 4 | 6 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 1 to 4 | 10 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 1 to 4 | 20 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 2 to 4 | 4 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 1 to 4 | 9 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 2 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 1 to 4 | 14 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 2 to 4 | 3 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 3 to 4 | 3 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 1 to 4 | 12 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 2 to 4 | 3 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 1 to 4 | 11 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 2 to 4 | 5 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 3 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 1 to 4 | 14 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 2 to 4 | 6 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 1 to 4 | 6 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 2 to 4 | 6 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 3 to 4 | 3 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 1 to 4 | 17 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 2 to 4 | 10 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 3 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 1 to 4 | 20 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 1 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 2 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 1 to 4 | 7 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 2 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 1 to 4 | 4 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 2 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 1 to 4 | 4 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 2 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 3 to 4 | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 2 to 4 | 4 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 3 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 3 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 1 to 4 | 8 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 2 to 4 | 9 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 3 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 1 to 4 | 4 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 2 to 4 | 9 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 1 to 4 | 18 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 1 to 4 | 8 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 1 to 4 | 23 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 2 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 2 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 1 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 1 to 4 | 15 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 2 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 2 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 2 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 1 to 4 | 14 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 3 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 2 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 1 to 4 | 13 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 2 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 1 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 2 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 1 to 4 | 4 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 1 to 4 | 19 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 3 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 2 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 2 to 4 | 7 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 1 to 4 | 16 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 3 to 4 | 3 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 1 to 4 | 16 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 1 to 4 | 15 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 2 to 4 | 6 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 1 to 4 | 6 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 2 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 2 to 4 | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 1 to 4 | 4 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 1 to 4 | 15 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 2 to 4 | 5 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 3 to 4 | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 1 to 4 | 8 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 2 to 4 | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 1 to 4 | 7 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 1 to 4 | 5 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 1 to 4 | 18 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 2 to 4 | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 2 to 4 | 6 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 1 to 4 | 8 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 2 to 4 | 8 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 1 to 4 | 16 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 2 to 4 | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 1 to 4 | 19 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 1 to 4 | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 1 to 4 | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 2 to 4 | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 3 to 4 | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 1 to 4 | 12 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 1 to 4 | 14 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 2 to 4 | 11 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 1 to 4 | 5 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 1 to 4 | 8 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 2 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 1 to 4 | 22 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 2 to 4 | 8 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 1 to 4 | 10 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 2 to 4 | 6 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 3 to 4 | 3 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 1 to 4 | 9 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 3 to 4 | 2 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 2 to 4 | 7 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 3 to 4 | 3 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 1 to 4 | 15 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 2 to 4 | 3 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 1 to 4 | 8 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 1 to 4 | 5 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 1 to 4 | 12 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 1 to 4 | 9 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 1 to 4 | 2 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 2 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 3 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 1 to 4 | 14 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 2 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 1 to 4 | 9 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 2 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 1 to 4 | 6 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 1 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 1 to 4 | 15 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 1 to 4 | 13 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 2 to 4 | 7 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 2 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 1 to 4 | 3 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 1 to 4 | 8 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 2 to 4 | 2 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 1 to 4 | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 2 to 4 | 4 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 2 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 3 to 4 | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 2 to 4 | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 3 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 1 to 4 | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 1 to 4 | 5 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 1 to 4 | 7 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 2 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Aspartate aminotransferase increased, Increase to Grades 1 to 4 | 3 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | GGT increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 2 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 1 to 4 | 6 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypoalbuminemia, Increase to Grades 1 to 4 | 7 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 2 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alanine aminotransferase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hyperkalemia, Increase to Grades 1 to 4 | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypercalcemia, Increase to Grades 1 to 4 | 4 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine increased, Increase to Grades 2 to 4 | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypomagnesemia, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood lactate dehydrogenase increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 3 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 1 to 4 | 2 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 1 to 4 | 3 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 1 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypernatremia, Increase to Grades 1 to 4 | 3 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood bilirubin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Alkaline phosphatase increased, Increase to Grades 1 to 4 | 3 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypocalcemia, Increase to Grades 1 to 4 | 6 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hypermagnesemia, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CPK increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Chronic Kidney Disease, Increase to Grades 1 to 4 | 4 Participants |
Secondary
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 hematology parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.
Time frame: Up to 152 weeks
Population: Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 1 to 4 | 3 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 1 to 4 | 24 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 1 to 4 | 15 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 1 to 4 | 1 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 1 to 4 | 17 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 1 to 4 | 18 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 3 to 4 | 9 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 3 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 1 to 4 | 22 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 3 to 4 | 5 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 2 to 4 | 16 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 2 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 3 to 4 | 9 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 2 to 4 | 15 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 2 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 1 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 1 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 2 to 4 | 17 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 3 to 4 | 0 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 2 to 4 | 10 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 3 to 4 | 6 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 2 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 3 to 4 | 10 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 3 to 4 | 2 Participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 2 to 4 | 11 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 2 to 4 | 7 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 3 to 4 | 13 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 1 to 4 | 13 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 1 to 4 | 17 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 1 to 4 | 30 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 3 to 4 | 7 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 2 to 4 | 13 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 1 to 4 | 15 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 3 to 4 | 4 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 2 to 4 | 14 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 2 to 4 | 7 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 3 to 4 | 9 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 2 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 1 to 4 | 12 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 1 to 4 | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 1 to 4 | 1 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 3 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 2 to 4 | 20 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 2 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 1 to 4 | 2 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 1 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 3 to 4 | 4 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 2 to 4 | 0 Participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 2 to 4 | 13 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 1 to 4 | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 2 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 1 to 4 | 20 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 2 to 4 | 17 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 3 to 4 | 11 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 1 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 1 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 2 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 3 to 4 | 0 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 1 to 4 | 18 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 3 to 4 | 5 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 1 to 4 | 15 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 2 to 4 | 9 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 3 to 4 | 4 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 1 to 4 | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 2 to 4 | 3 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 3 to 4 | 1 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 1 to 4 | 12 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 2 to 4 | 6 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 3 to 4 | 2 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 1 to 4 | 23 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 2 to 4 | 12 Participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 3 to 4 | 10 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 2 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 2 to 4 | 5 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 1 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 3 to 4 | 4 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 2 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 1 to 4 | 4 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 3 to 4 | 9 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 2 to 4 | 4 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 1 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 2 to 4 | 13 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 3 to 4 | 3 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 3 to 4 | 9 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 1 to 4 | 9 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 2 to 4 | 14 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 2 to 4 | 7 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 1 to 4 | 15 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 1 to 4 | 1 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 3 to 4 | 3 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 2 to 4 | 9 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 1 to 4 | 19 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 3 to 4 | 6 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 3 to 4 | 0 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 1 to 4 | 21 Participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 1 to 4 | 6 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 1 to 4 | 7 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 1 to 4 | 5 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 2 to 4 | 3 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 1 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 2 to 4 | 5 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 2 to 4 | 6 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 3 to 4 | 1 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 1 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 1 to 4 | 9 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 2 to 4 | 4 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 1 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 1 to 4 | 6 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytosis, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 3 to 4 | 4 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 2 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Hemoglobin increased, Increase to Grades 1 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count decreased, Increase to Grades 1 to 4 | 6 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophil count decreased, Increase to Grades 3 to 4 | 4 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Eosinophilia, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lymphocyte count increased, Increase to Grades 3 to 4 | 0 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Anemia, Increase to Grades 3 to 4 | 4 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | White blood cell decreased, Increase to Grades 3 to 4 | 4 Participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelet count decreased, Increase to Grades 2 to 4 | 5 Participants |
Secondary
Objective Response Rate (ORR)
ORR was 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 \[sCR\]), 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=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 152 weeks
Population: Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Objective Response Rate (ORR) | 33 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Objective Response Rate (ORR) | 25 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Objective Response Rate (ORR) | 28 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Objective Response Rate (ORR) | 25 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Objective Response Rate (ORR) | 18 Percentage of participants |
Secondary
Overall Survival (OS)
OS defined as the time from randomization until the date of death due to any cause.
Time frame: Up to 152 weeks
Population: Intent-to-Treat Population. Only those participants with documented death due to any cause have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Overall Survival (OS) | 20.9 Months |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Overall Survival (OS) | 15.0 Months |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Overall Survival (OS) | 13.5 Months |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Overall Survival (OS) | 14.5 Months |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Overall Survival (OS) | NA Months |
Secondary
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs
Percentage of participants requiring dose reduction, dose interruption/delay, permanent treatment discontinuation due to any AEs were presented. 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. AEs were coded using the standard MedDRA.
Time frame: Up to 152 weeks
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Reduction | 8 Percentage of participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Permanent Treatment Discontinuation | 10 Percentage of participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Interruption/Delay | 31 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Interruption/Delay | 23 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Reduction | 13 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Permanent Treatment Discontinuation | 8 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Interruption/Delay | 13 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Reduction | 5 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Permanent Treatment Discontinuation | 10 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Reduction | 5 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Permanent Treatment Discontinuation | 5 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Interruption/Delay | 10 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Interruption/Delay | 35 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Dose Reduction | 18 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs | Permanent Treatment Discontinuation | 18 Percentage of participants |
Secondary
Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events
The percentage of participants that required dose reduction, dose interruption/delay, permanent treatment discontinuation due to corneal events were evaluated using KVA Scale. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
Time frame: Up to 152 weeks
Population: Safety Population. Only those participants who experienced corneal events have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Reduction | 31 Percentage of participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Permanent Treatment Discontinuation | 0 Percentage of participants |
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Interruption/Delay | 59 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Interruption/Delay | 35 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Reduction | 28 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Permanent Treatment Discontinuation | 3 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Interruption/Delay | 28 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Reduction | 26 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Permanent Treatment Discontinuation | 0 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Reduction | 23 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Permanent Treatment Discontinuation | 0 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Interruption/Delay | 33 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Interruption/Delay | 29 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Dose Reduction | 35 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events | Permanent Treatment Discontinuation | 6 Percentage of participants |
Secondary
Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)
Percentage of participants with a confirmed VGPR or better defined as percentage of participant with confirmed VGPR, CR, and sCR, according to the 2016 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=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.
Time frame: Up to 152 weeks
Population: Intent-to-Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR) | 25 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR) | 18 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR) | 8 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR) | 15 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR) | 18 Percentage of participants |
Secondary
Percentage of Participants With AEs
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. AEs were coded using the standard Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: Up to 152 weeks
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Participants With AEs | 100 Percentage of participants |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Participants With AEs | 100 Percentage of participants |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Participants With AEs | 100 Percentage of participants |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Participants With AEs | 100 Percentage of participants |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Participants With AEs | 100 Percentage of participants |
Secondary
Percentage of Time on Study With Grade 2 or Above Corneal Events
It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below.
Time frame: Up to 152 weeks
Population: Safety Population. Only those participants who experienced corneal events of Grade 2 or above have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Percentage of Time on Study With Grade 2 or Above Corneal Events | 23.27 Percentage of Time |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Percentage of Time on Study With Grade 2 or Above Corneal Events | 24.86 Percentage of Time |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Percentage of Time on Study With Grade 2 or Above Corneal Events | 18.99 Percentage of Time |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Percentage of Time on Study With Grade 2 or Above Corneal Events | 23.67 Percentage of Time |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Percentage of Time on Study With Grade 2 or Above Corneal Events | 35.63 Percentage of Time |
Secondary
Progression Free Survival (PFS)
PFS defined as the time from randomization until the earliest date of documented PD, according to the 2016 IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
Time frame: Up to 152 weeks
Population: Intent-to-Treat Population. Only those participants with documented PD or death due to any cause have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Progression Free Survival (PFS) | 5.7 Months |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Progression Free Survival (PFS) | 2.1 Months |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Progression Free Survival (PFS) | 2.8 Months |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Progression Free Survival (PFS) | 2.7 Months |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Progression Free Survival (PFS) | 2.8 Months |
Secondary
Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC
Plasma samples were collected for PK analysis for belantamab mafodotin ADC.
Time frame: C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15
Population: Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC | 10.0 Liter | Geometric Coefficient of Variation 19.6 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC | 9.3 Liter | Geometric Coefficient of Variation 26.4 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC | 9.4 Liter | Geometric Coefficient of Variation 26.9 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC | 8.9 Liter | Geometric Coefficient of Variation 25.4 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC | 10.0 Liter | Geometric Coefficient of Variation 16.1 |
Secondary
Time to Progression (TTP)
TTP defined as the time from randomization until the earliest date of documented PD or death due to PD, according to the 2016 IMWG response criteria. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
Time frame: Up to 152 weeks
Population: Intent-to-Treat Population. Only those participants with documented PD or death due to PD have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Time to Progression (TTP) | 6.0 Months |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Time to Progression (TTP) | 2.1 Months |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Time to Progression (TTP) | 2.8 Months |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Time to Progression (TTP) | 2.7 Months |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Time to Progression (TTP) | 2.9 Months |
Secondary
Time to Response (TTR)
TTR 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 (i.e., confirmed PR or better), according to the 2016 IMWG response criteria. 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 152 weeks
Population: Intent-to-Treat Population. Only those participants with confirmed partial response (PR) or better (i.e., PR, VGPR, CR and sCR) have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Time to Response (TTR) | 0.8 Months |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Time to Response (TTR) | 1.1 Months |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Time to Response (TTR) | 0.7 Months |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Time to Response (TTR) | 0.8 Months |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Time to Response (TTR) | 1.5 Months |
Secondary
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 152 weeks
Population: Safety Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Secondary
Toxicity Index (TI)
Toxicity Index is a composite score derived from the severity grades of adverse events (AEs) reported during the study, based on the Common Terminology Criteria for Adverse Events (CTCAE). A participant's score is calculated as a function of the ordered toxicity grades, represented in descending order by sequence, on a scale of 0-6, where 0 represents no toxicity and 6 represents the highest toxicity. CTCAE grades are defined as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences), and Grade 5 (Death related to AE). Higher grades indicate greater toxicity severity.
Time frame: Up to 152 weeks
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | Toxicity Index (TI) | 3.68 Score on scale | Standard Deviation 1.078 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | Toxicity Index (TI) | 3.83 Score on scale | Standard Deviation 1.017 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | Toxicity Index (TI) | 3.87 Score on scale | Standard Deviation 1.092 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | Toxicity Index (TI) | 3.43 Score on scale | Standard Deviation 1.031 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | Toxicity Index (TI) | 3.64 Score on scale | Standard Deviation 0.892 |