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NCT03544281 · OUTCOME

C-EOI for Belantamab Mafodotin (Total Antibody), 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 5 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 at indicated timepoints 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/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex12
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex16

Reported measurements

CYCLE 1 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex10
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex3
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex12
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex16
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex42.70Not reported35.064.0Not reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex36.90Not reported35.347.9Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex27.25Not reported20.132.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex47.00Not reported17.264.2Not 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/Dex35.00Not reported27.840.3Not 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/Dex9
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/Dex42.15Not reported32.448.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex27.00Not reported24.736.4Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex45.70Not reported30.079.9Not reported
WEEK 5 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/Dex9
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/Dex36.40Not reported27.850.6Not 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/Dex41.80Not reported33.152.9Not reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/DexNANot reported44.444.4As 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/Dex31.25Not reported22.946.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/DexNANot reported38.652.1As 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/Dex39.20Not reported27.456.8Not 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 reported28.128.1As 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/DexNANot reported24.036.3As 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/Dex50.10Not reported39.573.3Not 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/Dex2
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/DexNANot reported32.344.8As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.0
        upper Limit
        64.0
        value
        42.70
      2. group Id
        OG001
        lower Limit
        35.3
        upper Limit
        47.9
        value
        36.90
      3. group Id
        OG002
        lower Limit
        20.1
        upper Limit
        32.7
        value
        27.25
      4. group Id
        OG003
        lower Limit
        17.2
        upper Limit
        64.2
        value
        47.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        16
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        27.8
        upper Limit
        40.3
        value
        35.00
    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
        32.4
        upper Limit
        48.1
        value
        42.15
      2. group Id
        OG002
        lower Limit
        24.7
        upper Limit
        36.4
        value
        27.00
      3. group Id
        OG003
        lower Limit
        30.0
        upper Limit
        79.9
        value
        45.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      units
      Participants
    title
    WEEK 5 DAY 1
  4. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        27.8
        upper Limit
        50.6
        value
        36.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    WEEK 5 DAY 8
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.1
        upper Limit
        52.9
        value
        41.80
      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
        44.4
        upper Limit
        44.4
        value
        NA
      3. group Id
        OG002
        lower Limit
        22.9
        upper Limit
        46.6
        value
        31.25
      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
        38.6
        upper Limit
        52.1
        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
        27.4
        upper Limit
        56.8
        value
        39.20
    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
        28.1
        upper Limit
        28.1
        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
        24.0
        upper Limit
        36.3
        value
        NA
      3. group Id
        OG003
        lower Limit
        39.5
        upper Limit
        73.3
        value
        50.10
    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. 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
        32.3
        upper Limit
        44.8
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    WEEK 13 DAY 8
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      16
    units
    Participants
description
Blood samples were collected at indicated timepoints 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 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
title
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice