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NCT06160609 · OUTCOME

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

Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM · Source last updated 2024-03-12

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 170 weeks

What was measured

Blood samples were collected for the analysis of following hematology parameters: eosinophils, anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, leukocytosis and white blood cell decreased. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented.

Analysis population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

Groups in this outcome

1.9 mg/kg Belantamab Mafodotin + 8mg OX40

Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.

2.5 mg/kg Belantamab Mafodotin + 8mg OX40

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.

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 + 8mg OX406
2.5 mg/kg Belantamab Mafodotin + 8mg OX403

Reported measurements

Eosinophils, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Eosinophils, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Eosinophils, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Anemia, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
Anemia, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Anemia, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Hemoglobin Increased, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Hemoglobin Increased, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Hemoglobin Increased, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Increased, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Increased, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Increased, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Neutrophil Count Decreased, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Neutrophil Count Decreased, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Neutrophil Count Decreased, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX402Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Leukocytosis, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
White Blood Cell Decreased, Increase to G1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
White Blood Cell Decreased, Increase to G2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX403Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
White Blood Cell Decreased, Increase to G3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Eosinophils, Increase to G1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Eosinophils, Increase to G2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Eosinophils, Increase to G3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Anemia, Increase to G1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Anemia, Increase to G2
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Anemia, Increase to G3
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin Increased, Increase to G1
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin Increased, Increase to G2
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin Increased, Increase to G3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Lymphocyte Count Decreased, Increase to G1
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Lymphocyte Count Decreased, Increase to G2
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Lymphocyte Count Decreased, Increase to G3
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Blood samples were collected for the analysis of following hematology parameters: eosinophils, anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, leukocytosis and white blood cell decreased. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented.
groups
  1. description
    Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.
    id
    OG000
    title
    1.9 mg/kg Belantamab Mafodotin + 8mg OX40
  2. description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
    id
    OG001
    title
    2.5 mg/kg Belantamab Mafodotin + 8mg OX40
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population included all participants who received at least 1 dose of any component of the combination therapy.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to 170 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