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NCT03544281 · OUTCOME

C-EOI 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 7 Day 11, 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/Dex11
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex11
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/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex16
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
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/Dex11
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/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex14
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex9
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/Dex36.60Not reported30.752.0Not reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex36.75Not reported27.644.0Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex52.55Not reported38.290.3Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex51.65Not reported43.766.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex23.90Not reported13.933.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex44.35Not reported30.363.0Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex33.40Not reported21.240.1Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex68.80Not reported42.5241.0Not 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/Dex10
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: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex24.95Not reported16.138.2Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex42.50Not reported25.798.9Not 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/Dex11
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/Dex8
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex16
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex7
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex10
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex39.20Not reported24.654.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex37.00Not reported19.846.0Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex59.50Not reported30.1233.0Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex39.40Not reported19.670.8Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex67.85Not reported50.085.5Not reported
WEEK 7 DAY 1

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex5
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex8
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex6
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex8
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex5
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex8
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex5
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex4
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex36.50Not reported31.867.8Not reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex43.00Not reported14.378.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex37.30Not reported23.365.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex47.50Not reported33.367.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex42.00Not reported24.049.5Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex50.75Not reported29.673.8Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex33.90Not reported20.263.0Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex63.95Not reported44.567.6Not 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/Dex2
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex2
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 reported32.260.4As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/DexNANot reported46.582.0As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
WEEK 7 DAY 11

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 reported34.934.9As 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/Dex2
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/Dex42.70Not reported41.053.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/DexNANot reported64.664.6As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/DexNANot reported31.644.2As 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 SPLIT + Bor/DexNANot reported36.936.9As 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 reported61.161.1As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
WEEK 10 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 reported40.740.7As 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/Dex1
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/Dex2
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex2
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex3
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/DexNANot reported37.037.0As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/DexNANot reported29.629.6As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex33.30Not reported27.841.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/DexNANot reported68.472.8As 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 reported37.651.2As 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 SPLIT + Bor/DexNANot reported49.549.5As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex54.50Not reported52.985.3Not reported
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 reported48.048.0As 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
        30.7
        upper Limit
        52.0
        value
        36.60
      2. group Id
        OG001
        lower Limit
        27.6
        upper Limit
        44.0
        value
        36.75
      3. group Id
        OG002
        lower Limit
        38.2
        upper Limit
        90.3
        value
        52.55
      4. group Id
        OG003
        lower Limit
        43.7
        upper Limit
        66.1
        value
        51.65
      5. group Id
        OG004
        lower Limit
        13.9
        upper Limit
        33.1
        value
        23.90
      6. group Id
        OG005
        lower Limit
        30.3
        upper Limit
        63.0
        value
        44.35
      7. group Id
        OG006
        lower Limit
        21.2
        upper Limit
        40.1
        value
        33.40
      8. group Id
        OG007
        lower Limit
        42.5
        upper Limit
        241.0
        value
        68.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        14
      7. group Id
        OG006
        value
        9
      8. group Id
        OG007
        value
        15
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        16.1
        upper Limit
        38.2
        value
        24.95
      2. group Id
        OG006
        lower Limit
        25.7
        upper Limit
        98.9
        value
        42.50
    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
        10
      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
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        24.6
        upper Limit
        54.6
        value
        39.20
      2. group Id
        OG004
        lower Limit
        19.8
        upper Limit
        46.0
        value
        37.00
      3. group Id
        OG005
        lower Limit
        30.1
        upper Limit
        233.0
        value
        59.50
      4. group Id
        OG006
        lower Limit
        19.6
        upper Limit
        70.8
        value
        39.40
      5. group Id
        OG007
        lower Limit
        50.0
        upper Limit
        85.5
        value
        67.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        16
      7. group Id
        OG006
        value
        7
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    WEEK 4 DAY 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.8
        upper Limit
        67.8
        value
        36.50
      2. group Id
        OG001
        lower Limit
        14.3
        upper Limit
        78.6
        value
        43.00
      3. group Id
        OG002
        lower Limit
        23.3
        upper Limit
        65.1
        value
        37.30
      4. group Id
        OG003
        lower Limit
        33.3
        upper Limit
        67.7
        value
        47.50
      5. group Id
        OG004
        lower Limit
        24.0
        upper Limit
        49.5
        value
        42.00
      6. group Id
        OG005
        lower Limit
        29.6
        upper Limit
        73.8
        value
        50.75
      7. group Id
        OG006
        lower Limit
        20.2
        upper Limit
        63.0
        value
        33.90
      8. group Id
        OG007
        lower Limit
        44.5
        upper Limit
        67.6
        value
        63.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        4
      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
        32.2
        upper Limit
        60.4
        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
        OG006
        lower Limit
        46.5
        upper Limit
        82.0
        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
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    WEEK 7 DAY 8
  6. 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
        34.9
        upper Limit
        34.9
        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 7 DAY 11
  7. categories
    1. measurements
      1. group Id
        OG002
        lower Limit
        41.0
        upper Limit
        53.6
        value
        42.70
      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
        64.6
        upper Limit
        64.6
        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
        31.6
        upper Limit
        44.2
        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
        36.9
        upper Limit
        36.9
        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
        61.1
        upper Limit
        61.1
        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
        2
      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
  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
        OG004
        lower Limit
        40.7
        upper Limit
        40.7
        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 10 DAY 8
  9. 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
        37.0
        upper Limit
        37.0
        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
        29.6
        upper Limit
        29.6
        value
        NA
      3. group Id
        OG002
        lower Limit
        27.8
        upper Limit
        41.6
        value
        33.30
      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
        68.4
        upper Limit
        72.8
        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
        OG005
        lower Limit
        37.6
        upper Limit
        51.2
        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
        OG006
        lower Limit
        49.5
        upper Limit
        49.5
        value
        NA
      7. group Id
        OG007
        lower Limit
        52.9
        upper Limit
        85.3
        value
        54.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        3
      units
      Participants
    title
    WEEK 13 DAY 1
  10. 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
        48.0
        upper Limit
        48.0
        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
      11
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      16
    7. group Id
      OG006
      value
      11
    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 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
title
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
type
SECONDARY
unit Of Measure
ug/mL

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Preserved source evidence · Not medical advice