Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03544281 · OUTCOME

C-EOI for Belantamab Mafodotin ADC, 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 10 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 1.9 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/Dex12
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/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12
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/Dex12
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/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex11
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in ug/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex44.75Not reported26.868.0Not reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex44.05Not reported36.161.5Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex52.00Not reported22.888.8Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex45.25Not reported31.476.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex22.30Not reported12.930.6Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex45.80Not reported29.157.6Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex30.10Not reported11.049.1Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex54.85Not reported37.2215.0Not 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/Dex13
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12
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/Dex22.60Not reported12.248.4Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex32.60Not reported17.555.7Not 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/Dex9
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex17
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex9
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/Dex46.00Not reported30.564.0Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex27.10Not reported16.732.4Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex44.50Not reported26.8254.0Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex26.20Not reported14.653.2Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex51.20Not reported45.757.8Not 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/Dex7
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/Dex48.60Not reported37.983.6Not reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex44.30Not reported3.471.8Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex36.45Not reported26.576.9Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex42.50Not reported25.984.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex26.30Not reported19.129.7Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex31.70Not reported18.262.7Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex27.40Not reported12.138.6Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex38.35Not reported37.055.8Not 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 reported21.032.6As 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 reported37.045.1As 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 reported19.119.1As 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/Dex38.00Not reported31.943.3Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/DexNANot reported81.881.8As 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 SPLIT + Bor/DexNANot reported24.933.2As 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 reported28.728.7As 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 reported60.360.3As 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 reported28.228.2As 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 reported33.333.3As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/DexNANot reported46.946.9As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex43.30Not reported31.160.1Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/DexNANot reported70.895.7As pre-specified in the SAP, median is not reported if the number of participants analyzed is less than 3.
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/DexNANot reported33.543.5As 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 SPLIT + Bor/DexNANot reported27.927.9As 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/Dex46.60Not reported41.462.3Not 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 reported37.037.0As 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
        26.8
        upper Limit
        68.0
        value
        44.75
      2. group Id
        OG001
        lower Limit
        36.1
        upper Limit
        61.5
        value
        44.05
      3. group Id
        OG002
        lower Limit
        22.8
        upper Limit
        88.8
        value
        52.00
      4. group Id
        OG003
        lower Limit
        31.4
        upper Limit
        76.7
        value
        45.25
      5. group Id
        OG004
        lower Limit
        12.9
        upper Limit
        30.6
        value
        22.30
      6. group Id
        OG005
        lower Limit
        29.1
        upper Limit
        57.6
        value
        45.80
      7. group Id
        OG006
        lower Limit
        11.0
        upper Limit
        49.1
        value
        30.10
      8. group Id
        OG007
        lower Limit
        37.2
        upper Limit
        215.0
        value
        54.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        18
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        16
      units
      Participants
    title
    CYCLE 1 DAY 1
  2. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        12.2
        upper Limit
        48.4
        value
        22.60
      2. group Id
        OG006
        lower Limit
        17.5
        upper Limit
        55.7
        value
        32.60
    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
        13
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 8
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        30.5
        upper Limit
        64.0
        value
        46.00
      2. group Id
        OG004
        lower Limit
        16.7
        upper Limit
        32.4
        value
        27.10
      3. group Id
        OG005
        lower Limit
        26.8
        upper Limit
        254.0
        value
        44.50
      4. group Id
        OG006
        lower Limit
        14.6
        upper Limit
        53.2
        value
        26.20
      5. group Id
        OG007
        lower Limit
        45.7
        upper Limit
        57.8
        value
        51.20
    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
        9
      6. group Id
        OG005
        value
        17
      7. group Id
        OG006
        value
        9
      8. group Id
        OG007
        value
        10
      units
      Participants
    title
    WEEK 4 DAY 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.9
        upper Limit
        83.6
        value
        48.60
      2. group Id
        OG001
        lower Limit
        3.4
        upper Limit
        71.8
        value
        44.30
      3. group Id
        OG002
        lower Limit
        26.5
        upper Limit
        76.9
        value
        36.45
      4. group Id
        OG003
        lower Limit
        25.9
        upper Limit
        84.1
        value
        42.50
      5. group Id
        OG004
        lower Limit
        19.1
        upper Limit
        29.7
        value
        26.30
      6. group Id
        OG005
        lower Limit
        18.2
        upper Limit
        62.7
        value
        31.70
      7. group Id
        OG006
        lower Limit
        12.1
        upper Limit
        38.6
        value
        27.40
      8. group Id
        OG007
        lower Limit
        37.0
        upper Limit
        55.8
        value
        38.35
    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
        7
      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
        21.0
        upper Limit
        32.6
        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
        37.0
        upper Limit
        45.1
        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
        19.1
        upper Limit
        19.1
        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
        31.9
        upper Limit
        43.3
        value
        38.00
      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
        81.8
        upper Limit
        81.8
        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
        24.9
        upper Limit
        33.2
        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
        28.7
        upper Limit
        28.7
        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
        60.3
        upper Limit
        60.3
        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
        28.2
        upper Limit
        28.2
        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
        33.3
        upper Limit
        33.3
        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
        46.9
        upper Limit
        46.9
        value
        NA
      3. group Id
        OG002
        lower Limit
        31.1
        upper Limit
        60.1
        value
        43.30
      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
        70.8
        upper Limit
        95.7
        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
        OG005
        lower Limit
        33.5
        upper Limit
        43.5
        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
        27.9
        upper Limit
        27.9
        value
        NA
      7. group Id
        OG007
        lower Limit
        41.4
        upper Limit
        62.3
        value
        46.60
    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
        37.0
        upper Limit
        37.0
        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
      12
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      13
    6. group Id
      OG005
      value
      18
    7. group Id
      OG006
      value
      12
    8. group Id
      OG007
      value
      16
    units
    Participants
description
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
dispersion Type
Full Range
groups
  1. description
    Participants with 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 10 Day 8, Week 13 Day 1, Week 13 Day 8
title
C-EOI for Belantamab Mafodotin ADC, Treatment B
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice