NCT06655818 · 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) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM · Source last updated 2025-03-03
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 153 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. 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 increase to G1, G2, G3, and G4 are presented. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Analysis population: Safety Population.
Groups in this outcome 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab Participants with Relapsed/Refractory Multiple Myeloma (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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).
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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 4
Reported measurements Eosinophilia, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Eosinophilia, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Eosinophilia, Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Eosinophilia, Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Anemia, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Anemia, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 1 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 1 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Lymphocyte count decreased, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Lymphocyte count decreased, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 2 Not reported Not reported Not reported Not reported
Lymphocyte count increased, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Lymphocyte count increased, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 1 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 1 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 1 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 1 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to Grade 3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 2 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to Grade 4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
White blood cell decreased, Increase to Grade 1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 Not reported Not reported Not reported Not reported
White blood cell decreased, Increase to Grade 2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 0 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 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab 1 Not reported Not reported Not reported Not reported
Complete source fields classes
title Eosinophilia, Increase to Grade 1
title Eosinophilia, Increase to Grade 2
title Eosinophilia, Increase to Grade 3
title Eosinophilia, Increase to Grade 4
title Anemia, Increase to Grade 1
title Anemia, Increase to Grade 2
title Anemia, Increase to Grade 3
title Anemia, Increase to Grade 4
title Hemoglobin increased, Increase to Grade 1
title Hemoglobin increased, Increase to Grade 2
title Hemoglobin increased, Increase to Grade 3
title Hemoglobin increased, Increase to Grade 4 Show more (12 of 36)
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. 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 increase to G1, G2, G3, and G4 are presented. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. groups
description Participants with Relapsed/Refractory Multiple Myeloma (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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).
id OG000
title 1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab
param Type COUNT_OF_PARTICIPANTS
population Description Safety Population.
reporting Status POSTED
time Frame Baseline (Day 1) and up to 153 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
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