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NCT03544281 · OUTCOME

Ctrough 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
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 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, 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 1.9 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/Dex4
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/Dex9
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex14
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex15

Reported measurements

CYCLE 1 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex4
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex9
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex9
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex14
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex15
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex3.13Not reported1.05.6Not reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex5.27Not reported2.110.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex1.53Not reported1.14.5Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex1.32Not reported0.68.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex5.88Not reported1.213.5Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex7.22Not reported1.717.2Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex9.59Not reported3.538.9Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex6.82Not reported1.417.4Not 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/Dex9
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex8
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12.30Not reported2.733.2Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12.05Not reported7.822.6Not reported
WEEK 4 DAY 1

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/Dex10
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/Dex6
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex5
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex8
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex7.97Not reported0.618.8Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex14.95Not reported1.227.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex3.62Not reported0.622.8Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11.20Not reported5.325.1Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex5.27Not reported1.913.2Not reported
WEEK 7 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex2
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex6
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex5
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex3
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex4
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex5
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex3
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/DexNANot reported2.75.7As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex7.66Not reported2.622.2Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex1.72Not reported1.46.5Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex2.32Not reported1.95.8Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex19.40Not reported10.334.0Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex1.35Not reported1.121.7Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex26.00Not reported19.131.0Not reported
WEEK 7 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/Dex1
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/DexNANot reported1.51.5As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
WEEK 10 DAY 1

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/Dex3
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex1
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex1
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex1
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex3.07Not reported1.43.4Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/DexNANot reported2.32.3As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/DexNANot reported16.616.6As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/DexNANot reported20.720.7As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/DexNANot reported23.023.0As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
WEEK 13 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex1
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/Dex4
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex2
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex2
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/DexNANot reported12.012.0As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex5.26Not reported1.310.5Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/DexNANot reported9.314.5As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/DexNANot reported32.332.3As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/DexNANot reported29.229.2As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/DexNANot reported10.018.9As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
WEEK 13 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/Dex0
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/DexNANot reported10.010.0As 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
        1.0
        upper Limit
        5.6
        value
        3.13
      2. group Id
        OG001
        lower Limit
        2.1
        upper Limit
        10.7
        value
        5.27
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        4.5
        value
        1.53
      4. group Id
        OG003
        lower Limit
        0.6
        upper Limit
        8.6
        value
        1.32
      5. group Id
        OG004
        lower Limit
        1.2
        upper Limit
        13.5
        value
        5.88
      6. group Id
        OG005
        lower Limit
        1.7
        upper Limit
        17.2
        value
        7.22
      7. group Id
        OG006
        lower Limit
        3.5
        upper Limit
        38.9
        value
        9.59
      8. group Id
        OG007
        lower Limit
        1.4
        upper Limit
        17.4
        value
        6.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        14
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        15
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        2.7
        upper Limit
        33.2
        value
        12.30
      2. group Id
        OG006
        lower Limit
        7.8
        upper Limit
        22.6
        value
        12.05
    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
        9
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        8
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 8
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.6
        upper Limit
        18.8
        value
        7.97
      2. group Id
        OG004
        lower Limit
        1.2
        upper Limit
        27.7
        value
        14.95
      3. group Id
        OG005
        lower Limit
        0.6
        upper Limit
        22.8
        value
        3.62
      4. group Id
        OG006
        lower Limit
        5.3
        upper Limit
        25.1
        value
        11.20
      5. group Id
        OG007
        lower Limit
        1.9
        upper Limit
        13.2
        value
        5.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        8
      units
      Participants
    title
    WEEK 4 DAY 1
  4. 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
        5.7
        value
        NA
      2. group Id
        OG001
        lower Limit
        2.6
        upper Limit
        22.2
        value
        7.66
      3. group Id
        OG002
        lower Limit
        1.4
        upper Limit
        6.5
        value
        1.72
      4. group Id
        OG003
        lower Limit
        1.9
        upper Limit
        5.8
        value
        2.32
      5. group Id
        OG004
        lower Limit
        10.3
        upper Limit
        34.0
        value
        19.40
      6. group Id
        OG005
        lower Limit
        1.1
        upper Limit
        21.7
        value
        1.35
      7. group Id
        OG006
        lower Limit
        19.1
        upper Limit
        31.0
        value
        26.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    WEEK 7 DAY 1
  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
        OG004
        lower Limit
        1.5
        upper Limit
        1.5
        value
        NA
    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
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    WEEK 7 DAY 8
  6. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        1.4
        upper Limit
        3.4
        value
        3.07
      2. 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
        2.3
        upper Limit
        2.3
        value
        NA
      3. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG004
        lower Limit
        16.6
        upper Limit
        16.6
        value
        NA
      4. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG006
        lower Limit
        20.7
        upper Limit
        20.7
        value
        NA
      5. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG007
        lower Limit
        23.0
        upper Limit
        23.0
        value
        NA
    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
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      units
      Participants
    title
    WEEK 10 DAY 1
  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
        12.0
        upper Limit
        12.0
        value
        NA
      2. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        10.5
        value
        5.26
      3. 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
        9.3
        upper Limit
        14.5
        value
        NA
      4. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG005
        lower Limit
        32.3
        upper Limit
        32.3
        value
        NA
      5. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG006
        lower Limit
        29.2
        upper Limit
        29.2
        value
        NA
      6. comment
        As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
        group Id
        OG007
        lower Limit
        10.0
        upper Limit
        18.9
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        2
      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
        OG006
        lower Limit
        10.0
        upper Limit
        10.0
        value
        NA
    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
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    WEEK 13 DAY 8
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      14
    7. group Id
      OG006
      value
      12
    8. group Id
      OG007
      value
      15
    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 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
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 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
title
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
type
SECONDARY
unit Of Measure
ug/mL

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Preserved source evidence · Not medical advice