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NCT06655818 · OUTCOME

DE Phase: Belantamab Mafodotin Concentrations for Plasma Antibody-Drug Conjugate (ADC)

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
Nanogram/ millilitre (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 Antibody-Drug Conjugate (ADC) 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 Nanogram/ millilitre (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 Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab25300.0Not reported1580032300Not reported
CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab26450.0Not reported1790031100Not reported
CYCLE 1 DAY 1, 24 HOURS

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab20400.0Not reported803022200Not reported
CYCLE 1 DAY 4

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab9110.0Not reported510014500Not reported
CYCLE 1 DAY 8

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab4830.0Not reported20406990Not reported
CYCLE 1 DAY 22

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab1
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0.0Not 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 Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab1295.0Not reported10501540Not reported
CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab2
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab41950.0Not reported3500048900Not reported
CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab1
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0.0Not 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 Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab27600.0Not reportedNot reportedNot reportedNot reported
END OF TREATMENT

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab1
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab0.0Not 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
        4
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15800
        upper Limit
        32300
        value
        25300.0
    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
        17900
        upper Limit
        31100
        value
        26450.0
    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
        8030
        upper Limit
        22200
        value
        20400.0
    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
        5100
        upper Limit
        14500
        value
        9110.0
    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
        2040
        upper Limit
        6990
        value
        4830.0
    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
        0.0
    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
        1050
        upper Limit
        1540
        value
        1295.0
    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
        35000
        upper Limit
        48900
        value
        41950.0
    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
        0.0
    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
        27600.0
    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
        0.0
    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 Antibody-Drug Conjugate (ADC) 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 Antibody-Drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
Nanogram/ millilitre (ng/mL)

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Preserved source evidence · Not medical advice