Skip to content
Triangle logo TriangleGet started
← Full study record

NCT07084896 · OUTCOME

CE Phase: Number of Participants With Post-baseline Positive 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
C2 D1, C4 D1, C6 D1, C9 D1, C12 D1, C18 D1, 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 tested in screening assay, and positive samples were further characterized for antibody titers.

Analysis population: Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

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

CYCLE 2 DAY 1

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat28
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0Not reportedNot reportedNot reportedNot reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W1Not reportedNot reportedNot reportedNot reported
CYCLE 4 DAY 1

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat22
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W18
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0Not reportedNot reportedNot reportedNot reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0Not reportedNot reportedNot reportedNot reported
CYCLE 6 DAY 1

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat13
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0Not reportedNot reportedNot reportedNot reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0Not reportedNot reportedNot reportedNot reported
CYCLE 9 DAY 1

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat7
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0Not reportedNot reportedNot reportedNot reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0Not reportedNot reportedNot reportedNot reported
CYCLE 12 DAY 1

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat5
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0Not reportedNot reportedNot reportedNot reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0Not reportedNot reportedNot reportedNot reported
CYCLE 18 DAY 1

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat4
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0Not reportedNot reportedNot reportedNot reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0Not reportedNot reportedNot reportedNot reported
END OF TREATMENT (~157 weeks)

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat26
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat1Not reportedNot reportedNot reportedNot reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    CYCLE 2 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    CYCLE 4 DAY 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    CYCLE 6 DAY 1
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    CYCLE 9 DAY 1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    CYCLE 12 DAY 1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    CYCLE 18 DAY 1
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    END OF TREATMENT (~157 weeks)
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      37
    units
    Participants
description
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
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
COUNT_OF_PARTICIPANTS
population Description
Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
reporting Status
POSTED
time Frame
C2 D1, C4 D1, C6 D1, C9 D1, C12 D1, C18 D1, End of Treatment (approximately 157 weeks)
title
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice