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NCT06655818 · OUTCOME

DE Phase: Belantamab Mafodotin Concentrations for Plasma Total Antibody

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 total antibody 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 Dostarlimab3
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0.0Not reported00Not 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 Dostarlimab31000.0Not reported2070034500Not 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 Dostarlimab32400.0Not reported1980041100Not reported
CYCLE 1 DAY 1, 24 HOURS

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab3
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab21400.0Not reported1260023600Not 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 Dostarlimab15000.0Not reported781017800Not 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 Dostarlimab8235.0Not reported453012000Not 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 Dostarlimab1140.0Not 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 Dostarlimab3625.0Not reported34803770Not 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 Dostarlimab45350.0Not reported3550055200Not 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 Dostarlimab2800.0Not 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 Dostarlimab48900.0Not 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 Dostarlimab628.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20700
        upper Limit
        34500
        value
        31000.0
    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
        19800
        upper Limit
        41100
        value
        32400.0
    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
        12600
        upper Limit
        23600
        value
        21400.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    CYCLE 1 DAY 1, 24 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7810
        upper Limit
        17800
        value
        15000.0
    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
        4530
        upper Limit
        12000
        value
        8235.0
    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
        1140.0
    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
        3480
        upper Limit
        3770
        value
        3625.0
    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
        35500
        upper Limit
        55200
        value
        45350.0
    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
        2800.0
    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
        48900.0
    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
        628.0
    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 total antibody 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 Total Antibody
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice