Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03544281 · OUTCOME

C-EOI for Belantamab Mafodotin (Cys-mcMMAF), 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
MEDIAN
Unit
ug/mL
Interval / dispersion
Full Range
Time frame
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

What was measured

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

Analysis population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been 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/Dex11
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/Dex14

Reported measurements

CYCLE 1 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex11
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/Dex14
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0.43Not reported0.31.6Not reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0.187Not reported0.1600.290Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0.19Not reported0.11.3Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0.29Not reported0.11.3Not 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 ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0.29Not reported0.20.9Not reported
WEEK 5 DAY 1

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/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex8
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex10
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0.16Not reported0.10.4Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0.13Not reported0.10.3Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0.28Not reported0.21.0Not reported
WEEK 7 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/Dex7
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0.23Not reported0.20.4Not reported
WEEK 9 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex6
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex8
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex2
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0.29Not reported0.20.5Not reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/DexNANot reported0.10.1As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0.13Not reported0.10.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/DexNANot reported0.20.2As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
WEEK 9 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/Dex6
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0.24Not reported0.20.4Not reported
WEEK 13 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex1
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex2
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex4
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/DexNANot reported0.40.4As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/DexNANot reported0.10.2As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0.68Not reported0.20.9Not reported
WEEK 13 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/Dex3
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0.243Not reported0.2070.248Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        1.6
        value
        0.43
      2. group Id
        OG001
        lower Limit
        0.160
        upper Limit
        0.290
        value
        0.187
      3. group Id
        OG002
        lower Limit
        0.1
        upper Limit
        1.3
        value
        0.19
      4. group Id
        OG003
        lower Limit
        0.1
        upper Limit
        1.3
        value
        0.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        14
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.2
        upper Limit
        0.9
        value
        0.29
    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
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        0.4
        value
        0.16
      2. group Id
        OG002
        lower Limit
        0.1
        upper Limit
        0.3
        value
        0.13
      3. group Id
        OG003
        lower Limit
        0.2
        upper Limit
        1.0
        value
        0.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        10
      units
      Participants
    title
    WEEK 5 DAY 1
  4. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.2
        upper Limit
        0.4
        value
        0.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    WEEK 7 DAY 8
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        0.5
        value
        0.29
      2. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG001
        lower Limit
        0.1
        upper Limit
        0.1
        value
        NA
      3. group Id
        OG002
        lower Limit
        0.1
        upper Limit
        0.7
        value
        0.13
      4. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG003
        lower Limit
        0.2
        upper Limit
        0.2
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        2
      units
      Participants
    title
    WEEK 9 DAY 1
  6. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.2
        upper Limit
        0.4
        value
        0.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    WEEK 9 DAY 8
  7. categories
    1. measurements
      1. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG000
        lower Limit
        0.4
        upper Limit
        0.4
        value
        NA
      2. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG002
        lower Limit
        0.1
        upper Limit
        0.2
        value
        NA
      3. group Id
        OG003
        lower Limit
        0.2
        upper Limit
        0.9
        value
        0.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    WEEK 13 DAY 1
  8. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.207
        upper Limit
        0.248
        value
        0.243
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    WEEK 13 DAY 8
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      14
    units
    Participants
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
dispersion Type
Full Range
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
MEDIAN
population Description
Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
title
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice