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NCT06160609 · OUTCOME

DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody

Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM · Source last updated 2024-03-12

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
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

What was measured

Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.

Analysis population: Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.

Groups in this outcome

1.9 mg/kg Belantamab Mafodotin + 8mg OX40

Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (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 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.

2.5 mg/kg Belantamab Mafodotin + 8mg OX40

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 in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX406
2.5 mg/kg Belantamab Mafodotin + 8mg OX403

Reported measurements

Cycle 1 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX403
2.5 mg/kg Belantamab Mafodotin + 8mg OX402
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400.0Not reported00Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400.0Not reported00Not reported
Cycle 1 Day 1, End Of Infusion

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX406
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4032650.0Not reported2960036400Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4049500.0Not reported3820056800Not reported
Cycle 1 Day 1, 2 hours

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX406
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4034500.0Not reported3000037000Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4046000.0Not reported3780053000Not reported
Cycle 1 Day 1, 24 hours

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX406
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4023650.0Not reported1850032900Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4036700.0Not reported2660041000Not reported
Cycle 1 Day 4

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX406
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4015900.0Not reported995022000Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4021500.0Not reported1630025100Not reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX405
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX409770.0Not reported746010400Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4018300.0Not reported1060021500Not reported
Cycle 1 Day 22

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX401
2.5 mg/kg Belantamab Mafodotin + 8mg OX400
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX402620.0Not reportedNot reportedNot reportedNot reported
Cycle 2 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX404
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX404105.0Not reported26005170Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX403740.0Not reported30708680Not reported
Cycle 2 Day 1, End Of Infusion

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX405
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4034000.0Not reported2930041800Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4052000.0Not reported4080056200Not reported
Cycle 4 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX403
2.5 mg/kg Belantamab Mafodotin + 8mg OX401
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX406910.0Not reported456011800Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX405430.0Not reportedNot reportedNot reportedNot reported
Cycle 4 Day 1, End Of Infusion

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX403
2.5 mg/kg Belantamab Mafodotin + 8mg OX401
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4040500.0Not reported3910040900Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4033200.0Not reportedNot reportedNot reportedNot reported
Cycle 6 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX401
2.5 mg/kg Belantamab Mafodotin + 8mg OX401
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4013100.0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX408720.0Not reportedNot reportedNot reportedNot reported
Cycle 6 Day 1, End Of Infusion

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX401
2.5 mg/kg Belantamab Mafodotin + 8mg OX401
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4047500.0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4040400.0Not reportedNot reportedNot reportedNot 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
        0
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Cycle 1 Day 1, Pre-Dose
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29600
        upper Limit
        36400
        value
        32650.0
      2. group Id
        OG001
        lower Limit
        38200
        upper Limit
        56800
        value
        49500.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1, End Of Infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30000
        upper Limit
        37000
        value
        34500.0
      2. group Id
        OG001
        lower Limit
        37800
        upper Limit
        53000
        value
        46000.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1, 2 hours
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18500
        upper Limit
        32900
        value
        23650.0
      2. group Id
        OG001
        lower Limit
        26600
        upper Limit
        41000
        value
        36700.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1, 24 hours
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9950
        upper Limit
        22000
        value
        15900.0
      2. group Id
        OG001
        lower Limit
        16300
        upper Limit
        25100
        value
        21500.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 4
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7460
        upper Limit
        10400
        value
        9770.0
      2. group Id
        OG001
        lower Limit
        10600
        upper Limit
        21500
        value
        18300.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 8
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2620.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Cycle 1 Day 22
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2600
        upper Limit
        5170
        value
        4105.0
      2. group Id
        OG001
        lower Limit
        3070
        upper Limit
        8680
        value
        3740.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 2 Day 1, Pre-Dose
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29300
        upper Limit
        41800
        value
        34000.0
      2. group Id
        OG001
        lower Limit
        40800
        upper Limit
        56200
        value
        52000.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 2 Day 1, End Of Infusion
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4560
        upper Limit
        11800
        value
        6910.0
      2. group Id
        OG001
        value
        5430.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Cycle 4 Day 1, Pre-Dose
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39100
        upper Limit
        40900
        value
        40500.0
      2. group Id
        OG001
        value
        33200.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Cycle 4 Day 1, End Of Infusion
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        13100.0
      2. group Id
        OG001
        value
        8720.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Cycle 6 Day 1, Pre-Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
dispersion Type
Full Range
groups
  1. description
    Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (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 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.
    id
    OG000
    title
    1.9 mg/kg Belantamab Mafodotin + 8mg OX40
  2. description
    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 in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
    id
    OG001
    title
    2.5 mg/kg Belantamab Mafodotin + 8mg OX40
param Type
MEDIAN
population Description
Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.
reporting Status
POSTED
time Frame
Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)
title
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice