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NCT03544281 · OUTCOME

Ctrough 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/Dex4
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/Dex12

Reported measurements

CYCLE 1 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex4
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/Dex12
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0.81Not reported0.62.0Not reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex3.39Not reported0.76.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex7.74Not reported1.99.9Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex3.16Not reported1.65.9Not 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/Dex11
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/Dex3.99Not reported0.912.3Not 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/Dex3
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex9
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex5
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex2.76Not reported1.18.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex12.40Not reported7.722.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex1.82Not reported0.84.5Not 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/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/Dex6.16Not reported2.522.6Not reported
WEEK 9 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/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex6
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/DexNANot reported2.72.7As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/DexNANot reported8.78.7As 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/Dex15.25Not reported11.229.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/DexNANot reported10.411.0As 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/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/Dex10.50Not reported1.310.5Not reported
WEEK 13 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex2
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/Dex3
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/DexNANot reported1.62.4As 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 reported12.119.2As 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/Dex10.70Not reported0.917.0Not 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/Dex1
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 reported10.510.5As 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
        0.6
        upper Limit
        2.0
        value
        0.81
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        6.1
        value
        3.39
      3. group Id
        OG002
        lower Limit
        1.9
        upper Limit
        9.9
        value
        7.74
      4. group Id
        OG003
        lower Limit
        1.6
        upper Limit
        5.9
        value
        3.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        12.3
        value
        3.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 8
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        8.1
        value
        2.76
      2. group Id
        OG002
        lower Limit
        7.7
        upper Limit
        22.6
        value
        12.40
      3. group Id
        OG003
        lower Limit
        0.8
        upper Limit
        4.5
        value
        1.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        5
      units
      Participants
    title
    WEEK 5 DAY 1
  4. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        2.5
        upper Limit
        22.6
        value
        6.16
    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 5 DAY 8
  5. 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
        2.7
        upper Limit
        2.7
        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
        OG001
        lower Limit
        8.7
        upper Limit
        8.7
        value
        NA
      3. group Id
        OG002
        lower Limit
        11.2
        upper Limit
        29.7
        value
        15.25
      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
        10.4
        upper Limit
        11.0
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        2
      units
      Participants
    title
    WEEK 9 DAY 1
  6. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        10.5
        value
        10.50
    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 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
        1.6
        upper Limit
        2.4
        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
        12.1
        upper Limit
        19.2
        value
        NA
      3. group Id
        OG003
        lower Limit
        0.9
        upper Limit
        17.0
        value
        10.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      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
        10.5
        upper Limit
        10.5
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    WEEK 13 DAY 8
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      12
    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
Ctrough 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