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NCT06160609 · OUTCOME

DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

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 cys- monomethyl auristatin-F (cys-mcMMAF).

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 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 OX400.00Not reported0.00.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400.00Not reported0.00.0Not 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 OX40404.00Not reported352.0741.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX40623.00Not reported343.0735.0Not 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 OX40489.00Not reported338.0811.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX40527.00Not reported515.0832.0Not 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 OX40766.50Not reported449.01760.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX401020.00Not reported722.01050.0Not 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 OX40360.50Not reported288.0752.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX40492.00Not reported309.0615.0Not 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 OX40120.00Not reported107.0235.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX40234.00Not reported172.0292.0Not 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 ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 8mg OX400.00Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400.00Not reportedNot reportedNot reportedNot reported
Cycle 2 Day 1, Pre-Dose

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 OX400.00Not reported0.00.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400.00Not reported0.00.0Not 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 OX40384.00Not reported262.0676.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX40625.00Not reported353.0796.0Not 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 OX400.00Not reported0.00.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400.00Not 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 OX40548.00Not reported268.0679.0Not reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX40268.00Not 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 OX400.00Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX400.00Not 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 OX40291.00Not reportedNot reportedNot reportedNot reported
2.5 mg/kg Belantamab Mafodotin + 8mg OX40179.00Not reportedNot reportedNot reportedNot 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
        6
      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
        352.0
        upper Limit
        741.0
        value
        404.00
      2. group Id
        OG001
        lower Limit
        343.0
        upper Limit
        735.0
        value
        623.00
    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
        338.0
        upper Limit
        811.0
        value
        489.00
      2. group Id
        OG001
        lower Limit
        515.0
        upper Limit
        832.0
        value
        527.00
    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
        449.0
        upper Limit
        1760.0
        value
        766.50
      2. group Id
        OG001
        lower Limit
        722.0
        upper Limit
        1050.0
        value
        1020.00
    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
        288.0
        upper Limit
        752.0
        value
        360.50
      2. group Id
        OG001
        lower Limit
        309.0
        upper Limit
        615.0
        value
        492.00
    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
        107.0
        upper Limit
        235.0
        value
        120.00
      2. group Id
        OG001
        lower Limit
        172.0
        upper Limit
        292.0
        value
        234.00
    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
        0.00
      2. group Id
        OG001
        value
        0.00
    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
        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
        5
      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
        262.0
        upper Limit
        676.0
        value
        384.00
      2. group Id
        OG001
        lower Limit
        353.0
        upper Limit
        796.0
        value
        625.00
    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
        0.0
        upper Limit
        0.0
        value
        0.00
      2. group Id
        OG001
        value
        0.00
    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
        268.0
        upper Limit
        679.0
        value
        548.00
      2. group Id
        OG001
        value
        268.00
    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
        0.00
      2. group Id
        OG001
        value
        0.00
    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 cys- monomethyl auristatin-F (cys-mcMMAF).
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 Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice