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NCT06655818 · OUTCOME

DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF

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, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks)

What was measured

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

Analysis population: Pharmacokinetic population. 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 Dostarlimab0.00Not reported0.00.0Not 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 Dostarlimab218.00Not reported147.0447.0Not reported
CYCLE 1 DAY 1, 2 HOURS

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 Dostarlimab376.00Not reported231.0556.0Not reported
CYCLE 1 DAY 1, 24 HOURS

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 Dostarlimab750.00Not reported547.01670.0Not reported
CYCLE 1 DAY 4

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 Dostarlimab549.50Not reported218.01780.0Not reported
CYCLE 1 DAY 8

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 Dostarlimab170.90Not reported67.1264.0Not reported
CYCLE 1 DAY 22

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 Dostarlimab0.00Not reportedNot reportedNot reportedNot 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 Dostarlimab0.00Not reported0.00.0Not 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 Dostarlimab555.00Not reported394.0716.0Not reported
CYCLE 4 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 Dostarlimab0.00Not reportedNot reportedNot reportedNot reported
CYCLE 4 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 Dostarlimab469.00Not reportedNot reportedNot reportedNot reported
END OF TREATMENT

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 Dostarlimab0.00Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
    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
        147.0
        upper Limit
        447.0
        value
        218.00
    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
        231.0
        upper Limit
        556.0
        value
        376.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        547.0
        upper Limit
        1670.0
        value
        750.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    CYCLE 1 DAY 1, 24 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        218.0
        upper Limit
        1780.0
        value
        549.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    CYCLE 1 DAY 4
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        67.1
        upper Limit
        264.0
        value
        170.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    CYCLE 1 DAY 8
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 22
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        394.0
        upper Limit
        716.0
        value
        555.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    CYCLE 2 DAY 1, END OF INFUSION
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    CYCLE 4 DAY 1, PRE-DOSE
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        469.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    CYCLE 4 DAY 1, END OF INFUSION
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      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 belantamab mafodotin cys-mcMMAF when administered intravenously in combination with dostarlimab.
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. Only those participants with data available at the specified data points were analyzed.
reporting Status
POSTED
time Frame
Predose, end of infusion (EOI), 2, and 24 hours postdose on Cycle 1 Day 1, and at Cycle 1 Day 4, Day 8, Day 22, Predose and EOI on Cycle 2 Day 1, Cycle 4 Day 1, and at end of treatment (approximately 153 weeks)
title
DE Phase: Belantamab Mafodotin Concentrations for Plasma Cys-mcMMAF
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice