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NCT07084896 · OUTCOME

DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (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, C30 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. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Groups in this outcome

DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat

In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (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 administered twice a day (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.

DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat

In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered 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.

DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID

In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W 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.

DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID

In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, 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.

DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID

In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-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.

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

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat10
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID10
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1

Reported measurements

CYCLE 2 DAY 1

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat9
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID7
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID8
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
CYCLE 4 DAY 1

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat5
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID6
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
CYCLE 6 DAY 1

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat6
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID4
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
CYCLE 9 DAY 1

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat5
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
CYCLE 12 DAY 1

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat5
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat1
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID2
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
CYCLE 18 DAY 1

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
CYCLE 30 DAY 1

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat1
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
END OF TREATMENT (~157 weeks)

Analysis denominator · Participants

GroupSource count
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat7
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat4
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID7
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID6
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    CYCLE 2 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 4 DAY 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 6 DAY 1
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 9 DAY 1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 12 DAY 1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 18 DAY 1
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    CYCLE 30 DAY 1
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    END OF TREATMENT (~157 weeks)
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      1
    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 DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (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 administered twice a day (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
    DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
  2. description
    In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered 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
    OG001
    title
    DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
  3. description
    In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W 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
    OG002
    title
    DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
  4. description
    In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, 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
    OG003
    title
    DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
  5. description
    In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-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
    OG004
    title
    DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
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. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
reporting Status
POSTED
time Frame
C2 D1, C4 D1, C6 D1, C9 D1, C12 D1, C18 D1, C30 D1, End of Treatment (approximately 157 weeks)
title
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice