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NCT07084896 · OUTCOME

CE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin

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), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1

What was measured

Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.

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.

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

Reported measurements

CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat32
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat0.00Not reported0.00.0Not reported
CYCLE 1 DAY 1, 30 MINUTES

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat33
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat146.00Not reported0.01510.0Not reported
CYCLE 1 DAY 1, 1 HOUR

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat34
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat487.00Not reported14.11570.0Not reported
CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat34
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat353.00Not reported21.2826.0Not reported
CYCLE 1 DAY 1, 4 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat32
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat192.00Not reported0.6774.0Not reported
CYCLE 1 DAY 1, 8 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat31
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat87.80Not reported0.0337.0Not reported
CYCLE 1 DAY 4, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat33
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat231.00Not reported57.41220.0Not reported
CYCLE 1 DAY 8, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat32
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat246.50Not reported62.1988.0Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat25
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat142.00Not reported0.0557.0Not reported
CYCLE 2 DAY 1, 30 MINUTES

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat25
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat390.00Not reported33.51250.0Not reported
CYCLE 2 DAY 1, 1 HOUR

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat25
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat448.00Not reported39.81640.0Not reported
CYCLE 2 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat25
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat444.00Not reported153.01290.0Not reported
CYCLE 2 DAY 1, 4 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat23
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat247.00Not reported84.8881.0Not reported
CYCLE 2 DAY 1, 8 HOURS

Analysis denominator · Participants

GroupSource count
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat25
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat154.00Not reported1.0756.0Not 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
        32
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        1510.0
        value
        146.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    CYCLE 1 DAY 1, 30 MINUTES
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.1
        upper Limit
        1570.0
        value
        487.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    CYCLE 1 DAY 1, 1 HOUR
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.2
        upper Limit
        826.0
        value
        353.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        774.0
        value
        192.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    CYCLE 1 DAY 1, 4 HOURS
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        337.0
        value
        87.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    CYCLE 1 DAY 1, 8 HOURS
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.4
        upper Limit
        1220.0
        value
        231.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    CYCLE 1 DAY 4, PRE-DOSE
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.1
        upper Limit
        988.0
        value
        246.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    CYCLE 1 DAY 8, PRE-DOSE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        557.0
        value
        142.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.5
        upper Limit
        1250.0
        value
        390.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    CYCLE 2 DAY 1, 30 MINUTES
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.8
        upper Limit
        1640.0
        value
        448.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    CYCLE 2 DAY 1, 1 HOUR
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        153.0
        upper Limit
        1290.0
        value
        444.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    CYCLE 2 DAY 1, 2 HOURS
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.
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
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), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1
title
CE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice