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NCT06655818 · OUTCOME

DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin

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
MEDIAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
Predose and end of infusion (EOI) on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, and at the end of treatment (approximately 153 weeks)

What was measured

Blood samples were collected for PK analysis of dostarlimab when administered intravenously in combination with belantamab mafodotin.

Analysis population: Pharmacokinetic population included all participants in the Safety population who had at least 1 non-missing PK assessment. Only those participants with data available at the specified data points were analyzed.

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

CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0.0Not reported0203000Not reported
CYCLE 1 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab52500.0Not reported0124000Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab2
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab43550.0Not reported2390063200Not reported
CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab2
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab224000.0Not reported149000299000Not reported
CYCLE 5 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab532.0Not reportedNot reportedNot reportedNot reported
CYCLE 5 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab312000.0Not reportedNot reportedNot reportedNot reported
END OF TREATMENT

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab2
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab35750.0Not reported1220059300Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        203000
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        124000
        value
        52500.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    CYCLE 1 DAY 1, END OF INFUSION
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23900
        upper Limit
        63200
        value
        43550.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        149000
        upper Limit
        299000
        value
        224000.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    CYCLE 2 DAY 1, END OF INFUSION
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        532.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    CYCLE 5 DAY 1, PRE-DOSE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        312000.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    CYCLE 5 DAY 1, END OF INFUSION
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12200
        upper Limit
        59300
        value
        35750.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    END OF TREATMENT
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Blood samples were collected for PK analysis of dostarlimab when administered intravenously in combination with belantamab mafodotin.
dispersion Type
Full Range
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
MEDIAN
population Description
Pharmacokinetic population included all participants in the Safety population who had at least 1 non-missing PK assessment. Only those participants with data available at the specified data points were analyzed.
reporting Status
POSTED
time Frame
Predose and end of infusion (EOI) on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, and at the end of treatment (approximately 153 weeks)
title
DE Phase: Dostarlimab Concentration When Administered in Combination With Belantamab Mafodotin
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice