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NCT03544281 · OUTCOME

Cmax for Belantamab Mafodotin (Total Antibody) Treatment B

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
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 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 1.9 mg/kg STRETCH + Bor/Dex

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

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

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/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 on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

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

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 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
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex10
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex13
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex17
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16

Reported measurements

CYCLE 1 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex10
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex13
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex17
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex10
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex41.2816.86Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex37.4712.02Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex53.2923.50Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex53.8512.54Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex22.9235.83Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex50.3230.03Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex31.0620.02Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex78.2936.16Not reportedNot reportedNot reported
CYCLE 1 DAY 8

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex0
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex29.4740.48Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex45.3139.57Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.86
        value
        41.28
      2. group Id
        OG001
        spread
        12.02
        value
        37.47
      3. group Id
        OG002
        spread
        23.50
        value
        53.29
      4. group Id
        OG003
        spread
        12.54
        value
        53.85
      5. group Id
        OG004
        spread
        35.83
        value
        22.92
      6. group Id
        OG005
        spread
        30.03
        value
        50.32
      7. group Id
        OG006
        spread
        20.02
        value
        31.06
      8. group Id
        OG007
        spread
        36.16
        value
        78.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        17
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        16
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG004
        spread
        40.48
        value
        29.47
      2. group Id
        OG006
        spread
        39.57
        value
        45.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        11
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 8
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      13
    6. group Id
      OG005
      value
      17
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      16
    units
    Participants
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG000
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
  2. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG001
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
  3. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG002
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
  4. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG003
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
  5. 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 on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG004
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
  6. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG005
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
  7. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG006
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
  8. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG007
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
param Type
GEOMETRIC_MEAN
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, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
title
Cmax for Belantamab Mafodotin (Total Antibody) Treatment B
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice