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NCT07217119 · OUTCOME

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

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM · Source last updated 2026-06-25

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 281 weeks.

What was measured

Blood samples were collected for evaluation of hematology parameters including Anemia, Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. 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. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.

Analysis population: Safety population

Groups in this outcome

1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).

2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

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

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab9
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab10
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab6

Reported measurements

Anemia, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
Anemia, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
Anemia, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
Anemia, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
HbI, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
HbI, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
HbI, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
HbI, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LyD, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
LyD, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
LyD, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab4Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
LyD, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LyI, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LyI, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LyI, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LyI, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
NeuD, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
NeuD, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab3Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
NeuD, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
NeuD, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
PD, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab3Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab4Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab4Not reportedNot reportedNot reportedNot reported
PD, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
PD, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
PD, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LC, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LC, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LC, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
LC, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
WBCD, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab3Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
WBCD, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab2Not reportedNot reportedNot reportedNot reported
WBCD, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
WBCD, Increase to G4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab1Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Anemia, Increase to G1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Anemia, Increase to G2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    Anemia, Increase to G3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Anemia, Increase to G4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    HbI, Increase to G1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    HbI, Increase to G2
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    HbI, Increase to G3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    HbI, Increase to G4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    LyD, Increase to G1
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    LyD, Increase to G2
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
    title
    LyD, Increase to G3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    LyD, Increase to G4
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Blood samples were collected for evaluation of hematology parameters including Anemia, Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. 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. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
    id
    OG000
    title
    1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
  2. description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
    id
    OG001
    title
    2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
  3. description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
    id
    OG002
    title
    2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 281 weeks.
title
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice