Skip to content
Triangle logo TriangleGet started
← Full study record

NCT07084896 · OUTCOME

CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM · Source last updated 2026-05-06

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
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, and D22; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (appoximately 157 weeks)

What was measured

Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.

Analysis population: Pharmacokinetic 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. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Groups in this outcome

CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat

In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W

In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.

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

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat34
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W37

Reported measurements

CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat23
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W20
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.0Not reported05050Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.0Not reported04580Not reported
CYCLE 1 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat34
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W36
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat17000.0Not reported036700Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W45150.0Not reported700081500Not reported
CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W36
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat17000.0Not reported969041100Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W46800.0Not reported2980075900Not reported
CYCLE 1 DAY 1, 24 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat30
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W34
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat12050.0Not reported406027500Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W36200.0Not reported1710073100Not reported
CYCLE 1 DAY 4, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W36
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat8005.0Not reported75022500Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W22050.0Not reported990039000Not reported
CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat29
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W36
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat3970.0Not reported014000Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W15150.0Not reported559030600Not reported
CYCLE 1 DAY 22, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W6
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W10630.0Not reported467013800Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat25
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W29
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat1760.0Not reported016700Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W5460.0Not reported025900Not reported
CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat28
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W31
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat21600.0Not reported038100Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W48400.0Not reported1650093000Not reported
CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat18
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W17
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat1935.0Not reported015700Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W8090.0Not reported108026600Not reported
CYCLE 4 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat22
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W16
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat20050.0Not reported707061500Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W46250.0Not reported22100196000Not reported
CYCLE 6 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat13
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W14
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat1110.0Not reported08320Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W3680.0Not reported62944500Not reported
CYCLE 6 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat13
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W14
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat20200.0Not reported947032500Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W37100.0Not reported249077300Not reported
CYCLE 9 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat6
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W9
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat6550.0Not reported380013300Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W9030.0Not reported106060400Not reported
CYCLE 9 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat6
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W9
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat29350.0Not reported1660037100Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W29600.0Not reported1490066300Not reported
CYCLE 12 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat5
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat7910.0Not reported155016600Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W6915.0Not reported72317700Not reported
CYCLE 12 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat5
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat33700.0Not reported1050038700Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W27950.0Not reported1510047600Not reported
CYCLE 18 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat4
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W5
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat6165.0Not reported40908820Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W6760.0Not reported91442500Not reported
END OF TREATMENT (~157 weeks)

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat22
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W20
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat2570.0Not reported016200Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W4050.0Not reported118022100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        5050
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        4580
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        36700
        value
        17000.0
      2. group Id
        OG001
        lower Limit
        7000
        upper Limit
        81500
        value
        45150.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    CYCLE 1 DAY 1, END OF INFUSION
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9690
        upper Limit
        41100
        value
        17000.0
      2. group Id
        OG001
        lower Limit
        29800
        upper Limit
        75900
        value
        46800.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4060
        upper Limit
        27500
        value
        12050.0
      2. group Id
        OG001
        lower Limit
        17100
        upper Limit
        73100
        value
        36200.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        34
      units
      Participants
    title
    CYCLE 1 DAY 1, 24 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        750
        upper Limit
        22500
        value
        8005.0
      2. group Id
        OG001
        lower Limit
        9900
        upper Limit
        39000
        value
        22050.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    CYCLE 1 DAY 4, ANYTIME SAMPLE
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        14000
        value
        3970.0
      2. group Id
        OG001
        lower Limit
        5590
        upper Limit
        30600
        value
        15150.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  7. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        4670
        upper Limit
        13800
        value
        10630.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    CYCLE 1 DAY 22, ANYTIME SAMPLE
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        16700
        value
        1760.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        25900
        value
        5460.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        38100
        value
        21600.0
      2. group Id
        OG001
        lower Limit
        16500
        upper Limit
        93000
        value
        48400.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    CYCLE 2 DAY 1, END OF INFUSION
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        15700
        value
        1935.0
      2. group Id
        OG001
        lower Limit
        1080
        upper Limit
        26600
        value
        8090.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    CYCLE 4 DAY 1, PRE-DOSE
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7070
        upper Limit
        61500
        value
        20050.0
      2. group Id
        OG001
        lower Limit
        22100
        upper Limit
        196000
        value
        46250.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    CYCLE 4 DAY 1, END OF INFUSION
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        8320
        value
        1110.0
      2. group Id
        OG001
        lower Limit
        629
        upper Limit
        44500
        value
        3680.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    CYCLE 6 DAY 1, PRE-DOSE
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      37
    units
    Participants
description
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
dispersion Type
Full Range
groups
  1. description
    In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG000
    title
    CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
  2. description
    In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
    id
    OG001
    title
    CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
param Type
MEDIAN
population Description
Pharmacokinetic 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. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
reporting Status
POSTED
time Frame
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, and D22; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (appoximately 157 weeks)
title
CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice