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NCT07150104 · OUTCOME

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

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants With RRMM · Source last updated 2026-06-25

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), and 2 hours postdose on Cycle 1 Day 1, anytime sample at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and at end of treatment (~137 weeks)

What was measured

Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC).

Analysis population: Pharmacokinetic (PK) population included all participants in the safety population from whom at least one PK sample has been obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Groups in this outcome

0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14

Reported measurements

CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone13
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.0Not reported00Not reported
CYCLE 1 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone12450.0Not reported355019400Not reported
CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11250.0Not reported696015900Not reported
CYCLE 1 DAY 4, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone13
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone3220.0Not reported9856620Not reported
CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone13
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1410.0Not reported02780Not reported
CYCLE 1 DAY 29, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone2
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.0Not reported00Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone13
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.0Not reported0609Not reported
CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone12
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11450.0Not reported661018700Not reported
CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone666.0Not reported013000Not reported
CYCLE 4 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone15100.0Not reported52929100Not reported
CYCLE 6 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone9
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone791.0Not reported01280Not reported
CYCLE 6 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone9
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone15000.0Not reported725025100Not reported
CYCLE 9 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone8
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1021.5Not reported02330Not reported
CYCLE 9 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone8
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone12100.0Not reported706034700Not reported
CYCLE 12 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone6
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone936.5Not reported01570Not reported
CYCLE 12 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone6
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14550.0Not reported781021300Not reported
CYCLE 18 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone3
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1270.0Not reported10601790Not reported
END OF TREATMENT (~137 weeks)

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone4
Values in Nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.0Not reported00Not 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
        13
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3550
        upper Limit
        19400
        value
        12450.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY 1, END OF INFUSION
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6960
        upper Limit
        15900
        value
        11250.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        985
        upper Limit
        6620
        value
        3220.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    CYCLE 1 DAY 4, ANYTIME SAMPLE
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2780
        value
        1410.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    CYCLE 1 DAY 29, ANYTIME SAMPLE
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        609
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6610
        upper Limit
        18700
        value
        11450.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    CYCLE 2 DAY 1, END OF INFUSION
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        13000
        value
        666.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    CYCLE 4 DAY 1, PRE-DOSE
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        529
        upper Limit
        29100
        value
        15100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    CYCLE 4 DAY 1, END OF INFUSION
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1280
        value
        791.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    CYCLE 6 DAY 1, PRE-DOSE
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7250
        upper Limit
        25100
        value
        15000.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    CYCLE 6 DAY 1, END OF INFUSION
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC).
dispersion Type
Full Range
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone
param Type
MEDIAN
population Description
Pharmacokinetic (PK) population included all participants in the safety population from whom at least one PK sample has been obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
reporting Status
POSTED
time Frame
Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1, anytime sample at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and at end of treatment (~137 weeks)
title
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
Nanogram/ millilitre (ng/mL)

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

Preserved source evidence · Not medical advice