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NCT07217184 · OUTCOME

DE Phase: Percentage 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 Isatuximab in Participants With RRMM · Source last updated 2026-06-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 194 weeks

What was measured

Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR 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 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 defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR 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

1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.

1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10

Reported measurements

Stringent Complete Response (sCR)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab20Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab10Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab10Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0Not reportedNot reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab30Not reportedNot reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0Not 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
        20
    title
    Stringent Complete Response (sCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        10
    title
    Complete Response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Very Good Partial Response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        0
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    units
    Participants
description
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR 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 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 defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR 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
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
  2. description
    Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG001
    title
    1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
  3. description
    Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG002
    title
    1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
param Type
NUMBER
population Description
Safety population
reporting Status
POSTED
time Frame
Up to approximately 194 weeks
title
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice