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NCT07150104 · OUTCOME

DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

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
Picogram / millilitre (pg/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 cys- monomethyl auristatin-F (cys-mcMMAF).

Analysis population: PK population. 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 + Dexamethasone14
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.00.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone71.55Not reported0.0181.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone104.50Not reported0.0210.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone106.00Not reported0.0188.0Not reported
CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.092.2Not reported
CYCLE 1 DAY 29, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone1
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reportedNANAFull range is not applicable as only a single participant was analyzed.
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone12
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.00.0Not reported
CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone57.80Not reported0.0197.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.097.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone86.30Not reported0.0329.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.00.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone68.60Not reported0.0303.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.00.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone58.40Not reported0.0566.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.00.0Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone28.40Not reported0.071.8Not 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 Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.00.0Not reported
END OF TREATMENT (~137 weeks)

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone5
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone0.00Not reported0.00.0Not 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
        14
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        181.0
        value
        71.55
    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
        0.0
        upper Limit
        210.0
        value
        104.50
    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
        0.0
        upper Limit
        188.0
        value
        106.00
    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
        0.0
        upper Limit
        92.2
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  6. categories
    1. measurements
      1. comment
        Full range is not applicable as only a single participant was analyzed.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 29, ANYTIME SAMPLE
  7. 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
        12
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        197.0
        value
        57.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    CYCLE 2 DAY 1, END OF INFUSION
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        97.0
        value
        0.00
    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
        0.0
        upper Limit
        329.0
        value
        86.30
    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
        0.0
        upper Limit
        0.0
        value
        0.00
    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
        0.0
        upper Limit
        303.0
        value
        68.60
    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 cys- monomethyl auristatin-F (cys-mcMMAF).
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
PK population. 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 Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
type
SECONDARY
unit Of Measure
Picogram / millilitre (pg/mL)

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Preserved source evidence · Not medical advice