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NCT06160609 · OUTCOME

DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)

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
nanogram/ millilitre (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 Antibody-Drug Conjugate (ADC).

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 OX404
2.5 mg/kg Belantamab Mafodotin + 8mg OX403
Values in nanogram/ millilitre (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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4030100.0Not reported2590036400Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4043400.0Not reported3140050000Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4029450.0Not reported2510032100Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4039700.0Not reported2980045800Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4018300.0Not reported1370027800Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4030900.0Not reported2000031000Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX409925.0Not reported624015500Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4010700.0Not reported942015500Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX403880.0Not reported35304880Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX407180.0Not reported51708220Not 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 OX401
Values in nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401060.0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX403130.0Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX401415.0Not reported8781700Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX401390.0Not reported6792720Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4027700.0Not reported2410033000Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4042900.0Not reported3250054000Not reported
Cycle 4 Day 1, Pre-Dose

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX402
2.5 mg/kg Belantamab Mafodotin + 8mg OX401
Values in nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX402635.0Not reported21903080Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX402190.0Not reportedNot reportedNot reportedNot reported
Cycle 4 Day 1, End Of Infusion

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX402
2.5 mg/kg Belantamab Mafodotin + 8mg OX401
Values in nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4028200.0Not reported2720029200Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4029900.0Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX403600.0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX402800.0Not 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 nanogram/ millilitre (ng/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX4032100.0Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX4027500.0Not 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
        4
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1, Pre-Dose
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25900
        upper Limit
        36400
        value
        30100.0
      2. group Id
        OG001
        lower Limit
        31400
        upper Limit
        50000
        value
        43400.0
    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
        25100
        upper Limit
        32100
        value
        29450.0
      2. group Id
        OG001
        lower Limit
        29800
        upper Limit
        45800
        value
        39700.0
    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
        13700
        upper Limit
        27800
        value
        18300.0
      2. group Id
        OG001
        lower Limit
        20000
        upper Limit
        31000
        value
        30900.0
    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
        6240
        upper Limit
        15500
        value
        9925.0
      2. group Id
        OG001
        lower Limit
        9420
        upper Limit
        15500
        value
        10700.0
    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
        3530
        upper Limit
        4880
        value
        3880.0
      2. group Id
        OG001
        lower Limit
        5170
        upper Limit
        8220
        value
        7180.0
    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
        1060.0
      2. group Id
        OG001
        value
        3130.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Cycle 1 Day 22
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        878
        upper Limit
        1700
        value
        1415.0
      2. group Id
        OG001
        lower Limit
        679
        upper Limit
        2720
        value
        1390.0
    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
        24100
        upper Limit
        33000
        value
        27700.0
      2. group Id
        OG001
        lower Limit
        32500
        upper Limit
        54000
        value
        42900.0
    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
        2190
        upper Limit
        3080
        value
        2635.0
      2. group Id
        OG001
        value
        2190.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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
        27200
        upper Limit
        29200
        value
        28200.0
      2. group Id
        OG001
        value
        29900.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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
        3600.0
      2. group Id
        OG001
        value
        2800.0
    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 Antibody-Drug Conjugate (ADC).
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 Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
nanogram/ millilitre (ng/mL)

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Preserved source evidence · Not medical advice