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NCT07084896 · OUTCOME

CE Phase: Titer of ADAs Against Belantamab Mafodotin

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
Titer
Interval / dispersion
Full Range
Time frame
C2 D1 and at End of Treatment (approximately 157 weeks)

What was measured

Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further tested in screening assay, and positive samples were further characterized for antibody titers.

Analysis population: Safety Population. Only those participants with positive ADA data available at the specified timepoint is presented.

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 + Nirogacestat1
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W1

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W1
Values in Titer · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W100Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
End of Treatment (~157 weeks)

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat1
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0
Values in Titer · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat400.0Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        400.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    End of Treatment (~157 weeks)
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further tested in screening assay, and positive samples were further characterized for antibody titers.
dispersion Type
Full Range
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 positive ADA data available at the specified timepoint is presented.
reporting Status
POSTED
time Frame
C2 D1 and at End of Treatment (approximately 157 weeks)
title
CE Phase: Titer of ADAs Against Belantamab Mafodotin
type
SECONDARY
unit Of Measure
Titer

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

Preserved source evidence · Not medical advice