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NCT07150104 · OUTCOME

DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin

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
ng/mL
Interval / dispersion
Full Range
Time frame
Predose, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 1 Day -2; Predose on Cycle 1 Day 1, 4, 8; Predose, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 2 Day 1

What was measured

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

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 -2, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone13
Values in ng/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 -2, 30 MINUTES

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone13
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone449.00Not reported0.0771.0Not reported
CYCLE 1 DAY -2, 1 HOUR

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone453.00Not reported0.0912.0Not reported
CYCLE 1 DAY -2, 2 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone294.00Not reported7.2582.0Not reported
CYCLE 1 DAY -2, 4 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone147.50Not reported88.6271.0Not reported
CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone93.20Not reported20.5885.0Not reported
CYCLE 1 DAY 4, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone12
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone110.50Not reported64.6441.0Not reported
CYCLE 1 DAY 8, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone14
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone133.00Not reported31.3306.0Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone13
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone106.00Not reported0.0751.0Not reported
CYCLE 2 DAY 1, 30 MINUTES

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone12
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone415.50Not reported0.01010.0Not reported
CYCLE 2 DAY 1, 1 HOUR

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone11
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone429.00Not reported0.81150.0Not reported
CYCLE 2 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone433.50Not reported18.3864.0Not reported
CYCLE 2 DAY 1, 4 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone217.50Not reported91.1425.0Not 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
        13
      units
      Participants
    title
    CYCLE 1 DAY -2, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        771.0
        value
        449.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    CYCLE 1 DAY -2, 30 MINUTES
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        912.0
        value
        453.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY -2, 1 HOUR
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.2
        upper Limit
        582.0
        value
        294.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY -2, 2 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        88.6
        upper Limit
        271.0
        value
        147.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY -2, 4 HOURS
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.5
        upper Limit
        885.0
        value
        93.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.6
        upper Limit
        441.0
        value
        110.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    CYCLE 1 DAY 4, PRE-DOSE
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.3
        upper Limit
        306.0
        value
        133.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY 8, PRE-DOSE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        751.0
        value
        106.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        1010.0
        value
        415.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    CYCLE 2 DAY 1, 30 MINUTES
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        1150.0
        value
        429.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    CYCLE 2 DAY 1, 1 HOUR
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.3
        upper Limit
        864.0
        value
        433.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    CYCLE 2 DAY 1, 2 HOURS
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    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
    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, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 1 Day -2; Predose on Cycle 1 Day 1, 4, 8; Predose, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 2 Day 1
title
DE Phase: Nirogacestat Concentration 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