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NCT07084896 · OUTCOME

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

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 (approximately 157 weeks)

What was measured

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

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 + Nirogacestat26
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W30
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.0Not reported00Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.0Not reported040500Not 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 Q3W35
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat19150.0Not reported040700Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W53800.0Not reported180091200Not reported
CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat33
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 + Nirogacestat17400.0Not reported1050053200Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W52900.0Not reported2330087100Not 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 + Nirogacestat11300.0Not reported300026500Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W31400.0Not reported1300065500Not 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 Q3W37
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat6320.0Not reported55216300Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W16700.0Not reported548041000Not reported
CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat30
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W35
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat2735.0Not reported05000Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W7990.0Not reported289016600Not 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 Q3W2955.0Not reported17004130Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat24
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W28
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat561.0Not reported017600Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W1860.0Not reported03540Not 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 + Nirogacestat21400.0Not reported034900Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W50600.0Not reported1550097300Not reported
CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat19
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 + Nirogacestat522.0Not reported03030Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W1840.0Not reported07460Not 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 + Nirogacestat19050.0Not reported930040600Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W46500.0Not reported2670094300Not 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 + Nirogacestat0.0Not reported04950Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W1265.0Not reported033700Not 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 + Nirogacestat18700.0Not reported797036000Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W40600.0Not reported124089700Not 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 + Nirogacestat2590.0Not reported6923570Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W2300.0Not reported022000Not 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 + Nirogacestat22350.0Not reported1940032200Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W30300.0Not reported1180073000Not 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 + Nirogacestat2920.0Not reported10104030Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W2140.0Not reported015100Not 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 + Nirogacestat21500.0Not reported1420037200Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W29750.0Not reported135039600Not 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 Q3W6
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat2105.0Not reported9334780Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W2330.0Not reported06690Not 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 Q3W18
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat857.0Not reported011900Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W1485.0Not reported08260Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        40500
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        30
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        40700
        value
        19150.0
      2. group Id
        OG001
        lower Limit
        1800
        upper Limit
        91200
        value
        53800.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    CYCLE 1 DAY 1, END OF INFUSION
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10500
        upper Limit
        53200
        value
        17400.0
      2. group Id
        OG001
        lower Limit
        23300
        upper Limit
        87100
        value
        52900.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      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
        3000
        upper Limit
        26500
        value
        11300.0
      2. group Id
        OG001
        lower Limit
        13000
        upper Limit
        65500
        value
        31400.0
    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
        552
        upper Limit
        16300
        value
        6320.0
      2. group Id
        OG001
        lower Limit
        5480
        upper Limit
        41000
        value
        16700.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    CYCLE 1 DAY 4, ANYTIME SAMPLE
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        5000
        value
        2735.0
      2. group Id
        OG001
        lower Limit
        2890
        upper Limit
        16600
        value
        7990.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  7. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        1700
        upper Limit
        4130
        value
        2955.0
    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
        17600
        value
        561.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        3540
        value
        1860.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        34900
        value
        21400.0
      2. group Id
        OG001
        lower Limit
        15500
        upper Limit
        97300
        value
        50600.0
    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
        3030
        value
        522.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        7460
        value
        1840.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      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
        9300
        upper Limit
        40600
        value
        19050.0
      2. group Id
        OG001
        lower Limit
        26700
        upper Limit
        94300
        value
        46500.0
    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
        4950
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        33700
        value
        1265.0
    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 Antibody-Drug Conjugate (ADC).
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 (approximately 157 weeks)
title
CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice