Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments · Source last updated 2025-08-19
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
Baseline (Day 1) and up to approximately 212 weeks
What was measured
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Analysis population: All treated population.
Groups in this outcome
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
3
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
4
Reported measurements
Anemia, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
3
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
3
Not reported
Not reported
Not reported
Not reported
Anemia, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
1
Not reported
Not reported
Not reported
Not reported
Anemia, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Hemoglobin increased, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Hemoglobin increased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Hemoglobin increased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Leukocytosis, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Leukocytosis, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Leukocytosis, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
White blood cell decreased, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
3
Not reported
Not reported
Not reported
Not reported
White blood cell decreased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
1
Not reported
Not reported
Not reported
Not reported
White blood cell decreased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
3
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
4
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Neutrophils, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
4
Not reported
Not reported
Not reported
Not reported
Neutrophils, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
0
Not reported
Not reported
Not reported
Not reported
Neutrophils, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
0
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
2
Not reported
Not reported
Not reported
Not reported
Platelets, Any Grade Increase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
3
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
4
Not reported
Not reported
Not reported
Not reported
Platelets, Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
1
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
1
Not reported
Not reported
Not reported
Not reported
Platelets, Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
2
Not reported
Not reported
Not reported
Not reported
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
title
Anemia, Any Grade Increase
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Anemia, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Anemia, Increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hemoglobin increased, Any Grade Increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hemoglobin increased, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hemoglobin increased, Increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Leukocytosis, Any Grade Increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Leukocytosis, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Leukocytosis, Increase to Grade 4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
title
White blood cell decreased, Any Grade Increase
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
White blood cell decreased, Increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
White blood cell decreased, Increase to Grade 4
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
4
units
Participants
description
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
groups
description
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
id
OG000
title
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
description
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
id
OG001
title
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated population.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 212 weeks
title
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Triangle