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NCT03544281 · OUTCOME

Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
Microgram/ millilitre (ug/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-Dose, 0, 2 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8

What was measured

Blood samples were collected at indicated timepoints for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

Analysis population: Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at the specified data points were analyzed.

Groups in this outcome

Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each 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
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex12
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex15

Reported measurements

CYCLE 1 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex12
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex15
Values in Microgram/ millilitre (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex43.5821.78Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex36.4117.06Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex25.2216.53Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex39.9925.03Not reportedNot reportedNot reported
CYCLE 1 DAY 8

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex12
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
Values in Microgram/ millilitre (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex27.6016.27Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.78
        value
        43.58
      2. group Id
        OG001
        spread
        17.06
        value
        36.41
      3. group Id
        OG002
        spread
        16.53
        value
        25.22
      4. group Id
        OG003
        spread
        25.03
        value
        39.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        15
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG002
        spread
        16.27
        value
        27.60
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 8
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      15
    units
    Participants
description
Blood samples were collected at indicated timepoints for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
    id
    OG000
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
  2. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG001
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
  3. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG002
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
  4. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG003
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at the specified data points were analyzed.
reporting Status
POSTED
time Frame
Pre-Dose, 0, 2 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8
title
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A
type
SECONDARY
unit Of Measure
Microgram/ millilitre (ug/mL)

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Preserved source evidence · Not medical advice