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NCT07084896 · OUTCOME

CE Phase: Progression-free Survival (PFS)

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM · Source last updated 2026-05-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 253 weeks

What was measured

PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.

Analysis population: Safety Population

Groups in this outcome

CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat

In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W

In CE Phase, 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 until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat34
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W37

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat3.5Not reported1.48.6Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W9.6Not reported4.220.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        8.6
        value
        3.5
      2. group Id
        OG001
        lower Limit
        4.2
        upper Limit
        20.2
        value
        9.6
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      37
    units
    Participants
description
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG000
    title
    CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
  2. description
    In CE Phase, 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 until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG001
    title
    CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
param Type
MEDIAN
population Description
Safety Population
reporting Status
POSTED
time Frame
Up to approximately 253 weeks
title
CE Phase: Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice