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NCT07150091 · OUTCOME

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

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM · Source last updated 2026-06-16

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 minutes, 1, 2, and 4 hours postdose on Cycle(C)1 Day -2; Predose on Day 1, 4, and 8 of C1; Predose, 30 minutes, 1, 2, and 4 hours postdose on C2 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 + Lenalidomide + 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; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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.

1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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 + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10

Reported measurements

CYCLE 1 DAY -2, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone0.00Not reported0.00.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + 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 + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone101.60Not reported0.0634.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone215.55Not reported0.01200.0Not reported
CYCLE 1 DAY-2, 1 HOUR

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone433.00Not reported0.0933.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone431.00Not reported6.6894.0Not reported
CYCLE 1 DAY-2, 2 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone284.50Not reported65.31540.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone329.00Not reported114.01460.0Not reported
CYCLE 1 DAY-2, 4 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone139.00Not reported24.8799.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone169.50Not reported96.4719.0Not reported
CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone125.00Not reported32.1421.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone89.85Not reported43.41130.0Not reported
CYCLE 1 DAY 4, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone10
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone244.00Not reported63.8972.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone199.00Not reported88.61760.0Not reported
CYCLE 1 DAY 8, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone9
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone9
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone231.00Not reported61.21040.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone164.00Not reported97.82750.0Not reported
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone9
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone126.00Not reported0.01200.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone140.55Not reported11.3568.0Not reported
CYCLE 2 DAY 1, 30 MINUTES

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone8
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone192.00Not reported0.91050.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone92.85Not reported3.9826.0Not reported
CYCLE 2 DAY 1, 1 HOUR

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone8
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone500.00Not reported57.71080.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone138.00Not reported11.1787.0Not reported
CYCLE 2 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone9
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone649.00Not reported49.62980.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone417.50Not reported17.61640.0Not reported
CYCLE 2 DAY 1, 4 HOURS

Analysis denominator · Participants

GroupSource count
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone9
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone8
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone311.00Not reported49.72770.0Not reported
1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone406.00Not reported144.01480.0Not 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
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY -2, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        634.0
        value
        101.60
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        1200.0
        value
        215.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY-2, 30 MINUTES
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        933.0
        value
        433.00
      2. group Id
        OG001
        lower Limit
        6.6
        upper Limit
        894.0
        value
        431.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY-2, 1 HOUR
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.3
        upper Limit
        1540.0
        value
        284.50
      2. group Id
        OG001
        lower Limit
        114.0
        upper Limit
        1460.0
        value
        329.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY-2, 2 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.8
        upper Limit
        799.0
        value
        139.00
      2. group Id
        OG001
        lower Limit
        96.4
        upper Limit
        719.0
        value
        169.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY-2, 4 HOURS
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        32.1
        upper Limit
        421.0
        value
        125.00
      2. group Id
        OG001
        lower Limit
        43.4
        upper Limit
        1130.0
        value
        89.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63.8
        upper Limit
        972.0
        value
        244.00
      2. group Id
        OG001
        lower Limit
        88.6
        upper Limit
        1760.0
        value
        199.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY 4, PRE-DOSE
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        61.2
        upper Limit
        1040.0
        value
        231.00
      2. group Id
        OG001
        lower Limit
        97.8
        upper Limit
        2750.0
        value
        164.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    CYCLE 1 DAY 8, PRE-DOSE
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        1200.0
        value
        126.00
      2. group Id
        OG001
        lower Limit
        11.3
        upper Limit
        568.0
        value
        140.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        1050.0
        value
        192.00
      2. group Id
        OG001
        lower Limit
        3.9
        upper Limit
        826.0
        value
        92.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    CYCLE 2 DAY 1, 30 MINUTES
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.7
        upper Limit
        1080.0
        value
        500.00
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        787.0
        value
        138.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    CYCLE 2 DAY 1, 1 HOUR
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.6
        upper Limit
        2980.0
        value
        649.00
      2. group Id
        OG001
        lower Limit
        17.6
        upper Limit
        1640.0
        value
        417.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    CYCLE 2 DAY 1, 2 HOURS
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    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; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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 + Lenalidomide + Dexamethasone
  2. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)\^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (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
    OG001
    title
    1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + 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 minutes, 1, 2, and 4 hours postdose on Cycle(C)1 Day -2; Predose on Day 1, 4, and 8 of C1; Predose, 30 minutes, 1, 2, and 4 hours postdose on C2 Day 1
title
DE 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