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NCT07150091 · OUTCOME

CE Phase: Number of Participants With AEs Leading to Discontinuation

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
Not reported
Unit
Not reported
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. Number of participants with AEs leading to discontinuation were to be evaluated.

Analysis population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

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 + Dexamethasone0
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    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. Number of participants with AEs leading to discontinuation were to be evaluated.
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
population Description
No participants were enrolled as CE Phase was not initiated due to business strategic reason.
reporting Status
POSTED
time Frame
Up to 143 weeks
title
CE Phase: Number of Participants With AEs Leading to Discontinuation
type
SECONDARY

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

Preserved source evidence · Not medical advice