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NCT07084896 · OUTCOME

DE Phase: Number of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)

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
NUMBER
Unit
Count of participants
Interval / dispersion
Not reported
Time frame
Up to approximately 253 weeks

What was measured

Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Analysis population: Safety Population

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

Stringent Complete Response (sCR)
Values in Count of 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 BID1Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in Count of 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
Very Good Partial Response (VGPR)
Values in Count of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat3Not 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 BID1Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Count of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat3Not 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 BID4Not reportedNot reportedNot reportedNot reported
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID3Not 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
        1
      5. group Id
        OG004
        value
        0
    title
    Stringent Complete Response (sCR)
  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
      5. group Id
        OG004
        value
        0
    title
    Complete Response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
    title
    Very Good Partial Response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Partial Response (PR)
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
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
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
NUMBER
population Description
Safety Population
reporting Status
POSTED
time Frame
Up to approximately 253 weeks
title
DE Phase: Number of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
type
SECONDARY
unit Of Measure
Count of participants

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Preserved source evidence · Not medical advice