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NCT06655818 · 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) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM · Source last updated 2025-03-03

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 153 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). 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; 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; 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.

Analysis population: Safety Population

Groups in this outcome

1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).

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 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4

Reported measurements

Stringent Complete Response (sCR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab25Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Stringent Complete Response (sCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Very Good Partial Response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    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). 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; 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; 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.
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).
    id
    OG000
    title
    1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab
param Type
NUMBER
population Description
Safety Population
reporting Status
POSTED
time Frame
Up to 153 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