Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05064358 · OUTCOME

Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-05-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 152 weeks

What was measured

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.

Analysis 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 (%).

Groups in this outcome

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.

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.

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.

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)38
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16

Reported measurements

Eosinophilia, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)32
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W25
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)31
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W22
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)3Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W1Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)2Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W1Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Eosinophilia, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)32
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W25
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)31
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W22
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)0Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Eosinophilia, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)32
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W25
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)31
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W22
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)0Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Anemia, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)38
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)17Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W15Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)20Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W15Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)6Not reportedNot reportedNot reportedNot reported
Anemia, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)38
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)16Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W14Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)17Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W14Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)5Not reportedNot reportedNot reportedNot reported
Anemia, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)38
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)10Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W9Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)11Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W9Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)4Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)38
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)1Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W1Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)38
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)0Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)38
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)0Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)2Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)2Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)2Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W0Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)0Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W0Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
White blood cell decreased, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)22Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W17Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)18Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W19Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)9Not reportedNot reportedNot reportedNot reported
White blood cell decreased, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)17Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W13Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)13Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W9Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)6Not reportedNot reportedNot reportedNot reported
White blood cell decreased, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)9Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W7Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)5Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W6Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)4Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)33
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W28
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W28
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)18Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W13Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)15Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W6Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)6Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)33
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W28
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W28
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)11Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W7Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)9Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W5Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)3Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)33
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W28
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W28
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)6Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W4Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)4Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W4Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)1Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)33
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W28
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W28
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)2Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W2Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)3Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W4Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)33
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W28
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W28
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)2Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W2Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)3Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W4Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)33
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W28
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W28
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)2Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W2Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)1Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W3Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)0Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)35
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W29
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W31
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)15Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W12Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)12Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W9Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)5Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)35
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W29
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W31
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)10Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W7Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)6Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W7Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)4Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)35
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W29
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)32
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W31
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)15
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)5Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W4Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)2Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W3Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)4Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Increase to Grades 1 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)24Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W30Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)23Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W21Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)7Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Increase to Grades 2 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)15Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W20Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)12Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W13Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)5Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Increase to Grades 3 to 4

Analysis denominator · Participants

GroupSource count
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)38
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W39
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)37
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W40
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)9Not reportedNot reportedNot reportedNot reported
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W13Not reportedNot reportedNot reportedNot reported
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)10Not reportedNot reportedNot reportedNot reported
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W9Not reportedNot reportedNot reportedNot reported
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        31
      4. group Id
        OG003
        value
        22
      5. group Id
        OG004
        value
        15
      units
      Participants
    title
    Eosinophilia, Increase to Grades 1 to 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        31
      4. group Id
        OG003
        value
        22
      5. group Id
        OG004
        value
        15
      units
      Participants
    title
    Eosinophilia, Increase to Grades 2 to 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        31
      4. group Id
        OG003
        value
        22
      5. group Id
        OG004
        value
        15
      units
      Participants
    title
    Eosinophilia, Increase to Grades 3 to 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        20
      4. group Id
        OG003
        value
        15
      5. group Id
        OG004
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Anemia, Increase to Grades 1 to 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        14
      5. group Id
        OG004
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Anemia, Increase to Grades 2 to 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Anemia, Increase to Grades 3 to 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Hemoglobin increased, Increase to Grades 1 to 4
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Hemoglobin increased, Increase to Grades 2 to 4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        38
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Hemoglobin increased, Increase to Grades 3 to 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        37
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Leukocytosis, Increase to Grades 1 to 4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        37
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Leukocytosis, Increase to Grades 2 to 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        37
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
      units
      Participants
    title
    Leukocytosis, Increase to Grades 3 to 4
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      38
    4. group Id
      OG003
      value
      40
    5. group Id
      OG004
      value
      16
    units
    Participants
description
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.
groups
  1. description
    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.
    id
    OG000
    title
    Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
  2. description
    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.
    id
    OG001
    title
    Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
  3. description
    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.
    id
    OG002
    title
    Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
  4. description
    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.
    id
    OG003
    title
    Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
  5. description
    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.
    id
    OG004
    title
    Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
param Type
COUNT_OF_PARTICIPANTS
population Description
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 (%).
reporting Status
POSTED
time Frame
Up to 152 weeks
title
Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice