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NCT04162210 · OUTCOME

Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Hematology

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2026-07-01

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 263 weeks

What was measured

Blood samples were collected for evaluation of hematology parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. \[White Blood Cells (WBC)\]

Analysis population: Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. Participants were counted more than once within some categories, hence the percentages may not add up to 100%.

Groups in this outcome

Belantamab Mafodotin

Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Pomalidomide Plus Dexamethasone

Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

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

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin217
Pomalidomide Plus Dexamethasone102

Reported measurements

Anemia, Increase (Inc) G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin215
Pomalidomide Plus Dexamethasone99
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin87Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone57Not reportedNot reportedNot reportedNot reported
Anemia, Inc G2-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin215
Pomalidomide Plus Dexamethasone99
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin73Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone39Not reportedNot reportedNot reportedNot reported
Anemia, Inc G3-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin215
Pomalidomide Plus Dexamethasone99
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin39Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone21Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Inc G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin215
Pomalidomide Plus Dexamethasone99
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin6Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Inc G2-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin215
Pomalidomide Plus Dexamethasone99
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin1Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Hemoglobin increased, Inc G3-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin215
Pomalidomide Plus Dexamethasone99
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin1Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Inc G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin105Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone71Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Inc G2-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin77Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone55Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased, Inc G3-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin43Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone27Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Inc G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin8Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Inc G2-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin8Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
Lymphocyte count increased, Inc G3-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin0Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Inc G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin96Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone83Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Inc G2-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin71Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone76Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased, Inc G3-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin32Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone58Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Inc G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin203
Pomalidomide Plus Dexamethasone90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin145Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone62Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Inc G2-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin203
Pomalidomide Plus Dexamethasone90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin98Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone38Not reportedNot reportedNot reportedNot reported
Platelet count decreased, Inc G3-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin203
Pomalidomide Plus Dexamethasone90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin67Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone21Not reportedNot reportedNot reportedNot reported
Eosi, Inc G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin205
Pomalidomide Plus Dexamethasone91
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin33Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone34Not reportedNot reportedNot reportedNot reported
WBC decreased, Inc G1-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin211
Pomalidomide Plus Dexamethasone95
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin91Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone83Not reportedNot reportedNot reportedNot reported
WBC decreased, Inc G2-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin211
Pomalidomide Plus Dexamethasone95
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin61Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone69Not reportedNot reportedNot reportedNot reported
WBC decreased, Inc G3-G4

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin211
Pomalidomide Plus Dexamethasone95
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin24Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone34Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        57
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Anemia, Increase (Inc) G1-G4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        39
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Anemia, Inc G2-G4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        21
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Anemia, Inc G3-G4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Hemoglobin increased, Inc G1-G4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Hemoglobin increased, Inc G2-G4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Hemoglobin increased, Inc G3-G4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        105
      2. group Id
        OG001
        value
        71
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Lymphocyte count decreased, Inc G1-G4
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        55
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Lymphocyte count decreased, Inc G2-G4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        27
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Lymphocyte count decreased, Inc G3-G4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Lymphocyte count increased, Inc G1-G4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Lymphocyte count increased, Inc G2-G4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        205
      2. group Id
        OG001
        value
        91
      units
      Participants
    title
    Lymphocyte count increased, Inc G3-G4
denoms
  1. counts
    1. group Id
      OG000
      value
      217
    2. group Id
      OG001
      value
      102
    units
    Participants
description
Blood samples were collected for evaluation of hematology parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. \[White Blood Cells (WBC)\]
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
    id
    OG000
    title
    Belantamab Mafodotin
  2. description
    Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
    id
    OG001
    title
    Pomalidomide Plus Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. Participants were counted more than once within some categories, hence the percentages may not add up to 100%.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 263 weeks
title
Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Hematology
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice