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NCT07084896 · OUTCOME

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

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
pg/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, 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 cys- monomethyl auristatin-F (cys-mcMMAF).

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.

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 + Nirogacestat33
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W37
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.00.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.00.0Not 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 pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat143.00Not reported0.0550.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W453.00Not reported0.01360.0Not 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 Q3W35
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat179.00Not reported69.3675.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W513.00Not reported175.02590.0Not reported
CYCLE 1 DAY 1, 24 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat31
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W32
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat291.00Not reported137.04960.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W778.00Not reported436.05970.0Not reported
CYCLE 1 DAY 4, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat33
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W36
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat237.00Not reported98.51470.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W548.00Not reported235.02530.0Not reported
CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat32
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W35
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat61.20Not reported0.0629.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W200.00Not reported81.9548.0Not reported
CYCLE 1 DAY 22, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat1
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W5
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.00.0Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat28
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W31
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.094.2Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.055.0Not 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 pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat126.00Not reported0.0698.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W329.00Not reported0.0684.0Not reported
CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat22
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W17
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.00.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.00.0Not 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 pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat128.50Not reported0.0293.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W351.50Not reported119.0987.0Not 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 Q3W13
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.00.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.0115.0Not 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 Q3W13
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat113.00Not reported54.4199.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W213.00Not reported0.0492.0Not reported
CYCLE 9 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 Q3W9
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.00.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.00.0Not reported
CYCLE 9 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 Q3W9
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat137.00Not reported59.6179.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W172.00Not reported0.0533.0Not 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 pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.00.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.052.5Not 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 Q3W7
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat112.00Not reported71.1210.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W261.00Not reported0.02120.0Not 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 pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.00.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.00.0Not reported
END OF TREATMENT (~157 weeks)

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat26
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W20
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.0276.0Not reported
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W0.00Not reported0.0162.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        550.0
        value
        143.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        1360.0
        value
        453.00
    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
        69.3
        upper Limit
        675.0
        value
        179.00
      2. group Id
        OG001
        lower Limit
        175.0
        upper Limit
        2590.0
        value
        513.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        137.0
        upper Limit
        4960.0
        value
        291.00
      2. group Id
        OG001
        lower Limit
        436.0
        upper Limit
        5970.0
        value
        778.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    CYCLE 1 DAY 1, 24 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98.5
        upper Limit
        1470.0
        value
        237.00
      2. group Id
        OG001
        lower Limit
        235.0
        upper Limit
        2530.0
        value
        548.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      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
        0.0
        upper Limit
        629.0
        value
        61.20
      2. group Id
        OG001
        lower Limit
        81.9
        upper Limit
        548.0
        value
        200.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  7. categories
    1. measurements
      1. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    CYCLE 1 DAY 22, ANYTIME SAMPLE
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        94.2
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        55.0
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        698.0
        value
        126.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        684.0
        value
        329.00
    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
        0.0
        upper Limit
        0.0
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      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
        0.0
        upper Limit
        293.0
        value
        128.50
      2. group Id
        OG001
        lower Limit
        119.0
        upper Limit
        987.0
        value
        351.50
    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
        0.0
        upper Limit
        0.0
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        115.0
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        13
      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 cys- monomethyl auristatin-F (cys-mcMMAF).
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.
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, 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 Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice