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NCT07150091 · OUTCOME

DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)

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
Up to 143 weeks

What was measured

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.

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

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone9Not reportedNot reportedNot reportedNot reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    units
    Participants
description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.
groups
  1. 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
  2. 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
Up to 143 weeks
title
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice