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NCT07084896 · OUTCOME

CE Phase: Duration of Response (DoR)

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

DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.

Analysis population: Safety Population. Only those participants with a confirmed PR or better as the best overall response (i.e., PR, VGPR, CR, and sCR) were assessed for this endpoint.

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 + Nirogacestat10
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W14

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + NirogacestatNANot reported4.2NAMedian and upper limit of 95% Confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W22.2Not reported4.9NAUpper limit of 95% Confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% Confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
        group Id
        OG000
        lower Limit
        4.2
        upper Limit
        NA
        value
        NA
      2. comment
        Upper limit of 95% Confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
        group Id
        OG001
        lower Limit
        4.9
        upper Limit
        NA
        value
        22.2
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      14
    units
    Participants
description
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
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. Only those participants with a confirmed PR or better as the best overall response (i.e., PR, VGPR, CR, and sCR) were assessed for this endpoint.
reporting Status
POSTED
time Frame
Up to approximately 253 weeks
title
CE Phase: Duration of Response (DoR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice