NCT07150091 · 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 Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM · Source last updated 2026-06-16
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 143 weeks What was measured Blood samples were collected for the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE version 5. 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. 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 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
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 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 10 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 10
Reported measurements Eosinophilia, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 4 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 5 Not reported Not reported Not reported Not reported
Eosinophilia, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Eosinophilia, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Eosinophilia, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Anemia, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Anemia, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported
Anemia, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported
Anemia, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Hemoglobin increased, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Lymphocyte count decreased, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Lymphocyte count decreased, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 3 Not reported Not reported Not reported Not reported
Lymphocyte count decreased, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 4 Not reported Not reported Not reported Not reported
Lymphocyte count decreased, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 3 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Lymphocyte count increased, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Lymphocyte count increased, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported
Lymphocyte count increased, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Lymphocyte count increased, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported
Neutrophil count decreased, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 3 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 4 Not reported Not reported Not reported Not reported
Platelet count decreased, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Leukocytosis, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
White blood cell decreased, Increase to G1 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 4 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 3 Not reported Not reported Not reported Not reported
White blood cell decreased, Increase to G2 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 3 Not reported Not reported Not reported Not reported
White blood cell decreased, Increase to G3 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 2 Not reported Not reported Not reported Not reported
White blood cell decreased, Increase to G4 Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 1 Not reported Not reported Not reported Not reported 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 4
group Id OG001
value 5
title Eosinophilia, Increase to G1 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Eosinophilia, Increase to G2 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Eosinophilia, Increase to G3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Eosinophilia, Increase to G4 categories measurements
group Id OG000
value 2
group Id OG001
value 0
title Anemia, Increase to G1 categories measurements
group Id OG000
value 2
group Id OG001
value 2
title Anemia, Increase to G2 categories measurements
group Id OG000
value 1
group Id OG001
value 1
title Anemia, Increase to G3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Anemia, Increase to G4 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Hemoglobin increased, Increase to G1 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Hemoglobin increased, Increase to G2 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Hemoglobin increased, Increase to G3 categories measurements
group Id OG000
value 0
group Id OG001
value 0
title Hemoglobin increased, Increase to G4 Show more (12 of 36) denoms counts
group Id OG000
value 10
group Id OG001
value 10
units Participants
description Blood samples were collected for the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE version 5. 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. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. groups
description Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
id OG000
title 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone
description Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
id OG001
title 1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone
param Type COUNT_OF_PARTICIPANTS
population Description Safety population.
reporting Status POSTED
time Frame Baseline (Day 1) and up to 143 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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