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NCT03544281 · OUTCOME

Change From Baseline in Vital Signs : Pulse Rate

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
MEAN
Unit
beats per minute
Interval / dispersion
Standard Deviation
Time frame
Baseline (Day 1) and up to approximately 4.5 years

What was measured

Pulse rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Analysis population: All treated population. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

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

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

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

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

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 1.9mg/kg STRETCH + Len/Dex12
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex16
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/Dex17
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

BASELINE (Day 1)

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex12
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex16
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/Dex17
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex72.89.01Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex73.811.90Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex76.017.10Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex72.814.65Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex73.713.05Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex76.212.69Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex75.511.21Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex79.613.36Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex73.314.31Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex74.110.76Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex81.010.05Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex75.310.82Not reportedNot reportedNot reported
WEEK 79 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex-9.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex-18.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-14.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex9.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex1.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex4.0Not reportedNot reportedNot reportedNot reported
WEEK 79 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex-6.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex-6.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex6.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-2.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex2.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex-9.0Not reportedNot reportedNot reportedNot reported
WEEK 79 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex-18.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex6.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex13.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-2.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex4.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex-6.0Not reportedNot reportedNot reportedNot reported
WEEK 91 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex0
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/Dex0
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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex1.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex-5.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex24.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-5.0Not reportedNot reportedNot reportedNot reported
WEEK 91 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex0
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/Dex0
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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex-2.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex-19.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex12.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-9.0Not reportedNot reportedNot reportedNot reported
WEEK 91 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex0
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/Dex0
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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex-6.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex-11.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex11.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-19.0Not reportedNot reportedNot reportedNot reported
WEEK 94 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex1
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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex-5.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-14.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex21.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex13.0Not reportedNot reportedNot reportedNot reported
WEEK 94 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex1
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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex-4.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-22.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex16.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12.0Not reportedNot reportedNot reportedNot reported
WEEK 94 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex1
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/Dex1
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex-4.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-28.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex11.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex14.0Not reportedNot reportedNot reportedNot reported
WEEK 109 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex1
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex3
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/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex1
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex-19.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex-22.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex8.35.13Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-6.08.49Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-12.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex-9.0Not reportedNot reportedNot reportedNot reported
WEEK 109 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex1
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex3
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/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex1
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex-18.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex-24.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0.33.06Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex10.541.72Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-16.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex-8.0Not reportedNot reportedNot reportedNot reported
WEEK 109 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex1
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex3
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/Dex1
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex1
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex-4.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex-25.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex1.35.69Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-8.011.31Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-12.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0.0Not reportedNot reportedNot reportedNot reported
WEEK 133 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex2
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/Dex1
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex6.59.19Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-11.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex-5.0Not reportedNot reportedNot reportedNot reported
WEEK 133 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex2
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/Dex1
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex4.50.71Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-12.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex-5.0Not reportedNot reportedNot reportedNot reported
WEEK 133 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex2
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/Dex1
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex5.52.12Not reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-16.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex-17.0Not reportedNot reportedNot reportedNot reported
WEEK 153 DAY 8, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex-8.0Not reportedNot reportedNot reportedNot reported
WEEK 153 DAY 8, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex-10.0Not reportedNot reportedNot reportedNot reported
WEEK 153 DAY 8, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex-9.0Not reportedNot reportedNot reportedNot reported
WEEK 169 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex2
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-15.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-21.05.66Not reportedNot reportedNot reported
WEEK 169 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex2
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-23.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-19.02.83Not reportedNot reportedNot reported
WEEK 169 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex2
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-20.0Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex-21.01.41Not reportedNot reportedNot reported
WEEK 169 DAY 8, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-21.0Not reportedNot reportedNot reportedNot reported
WEEK 169 DAY 8, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-17.0Not reportedNot reportedNot reportedNot reported
WEEK 169 DAY 8, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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 beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex-20.0Not reportedNot reportedNot reportedNot reported
WEEK 173 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex-7.0Not reportedNot reportedNot reportedNot reported
WEEK 173 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex-5.0Not reportedNot reportedNot reportedNot reported
WEEK 173 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex1
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex0
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex-8.0Not reportedNot reportedNot reportedNot reported
WEEK 221 DAY 1, Predose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex1
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex-4.0Not reportedNot reportedNot reportedNot reported
WEEK 221 DAY 1, 0.25hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex1
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex2.0Not reportedNot reportedNot reportedNot reported
WEEK 221 DAY 1, 1hour Post-Dose

Analysis denominator · Participants

GroupSource count
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex0
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex0
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex1
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/Dex0
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex0
Values in beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex8.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.01
        value
        72.8
      2. group Id
        OG001
        spread
        11.90
        value
        73.8
      3. group Id
        OG002
        spread
        17.10
        value
        76.0
      4. group Id
        OG003
        spread
        14.65
        value
        72.8
      5. group Id
        OG004
        spread
        13.05
        value
        73.7
      6. group Id
        OG005
        spread
        12.69
        value
        76.2
      7. group Id
        OG006
        spread
        11.21
        value
        75.5
      8. group Id
        OG007
        spread
        13.36
        value
        79.6
      9. group Id
        OG008
        spread
        14.31
        value
        73.3
      10. group Id
        OG009
        spread
        10.76
        value
        74.1
      11. group Id
        OG010
        spread
        10.05
        value
        81.0
      12. group Id
        OG011
        spread
        10.82
        value
        75.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        16
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        13
      10. group Id
        OG009
        value
        17
      11. group Id
        OG010
        value
        12
      12. group Id
        OG011
        value
        16
      units
      Participants
    title
    BASELINE (Day 1)
  2. categories
    1. measurements
      1. group Id
        OG004
        value
        -9.0
      2. group Id
        OG005
        value
        -18.0
      3. group Id
        OG008
        value
        -14.0
      4. group Id
        OG009
        value
        9.0
      5. group Id
        OG010
        value
        1.0
      6. group Id
        OG011
        value
        4.0
    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
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        1
      units
      Participants
    title
    WEEK 79 DAY 1, Predose
  3. categories
    1. measurements
      1. group Id
        OG004
        value
        -6.0
      2. group Id
        OG005
        value
        -6.0
      3. group Id
        OG008
        value
        6.0
      4. group Id
        OG009
        value
        -2.0
      5. group Id
        OG010
        value
        2.0
      6. group Id
        OG011
        value
        -9.0
    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
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        1
      units
      Participants
    title
    WEEK 79 DAY 1, 0.25hour Post-Dose
  4. categories
    1. measurements
      1. group Id
        OG004
        value
        -18.0
      2. group Id
        OG005
        value
        6.0
      3. group Id
        OG008
        value
        13.0
      4. group Id
        OG009
        value
        -2.0
      5. group Id
        OG010
        value
        4.0
      6. group Id
        OG011
        value
        -6.0
    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
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        1
      units
      Participants
    title
    WEEK 79 DAY 1, 1hour Post-Dose
  5. categories
    1. measurements
      1. group Id
        OG005
        value
        1.0
      2. group Id
        OG007
        value
        -5.0
      3. group Id
        OG008
        value
        24.0
      4. group Id
        OG009
        value
        -5.0
    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
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    WEEK 91 DAY 1, Predose
  6. categories
    1. measurements
      1. group Id
        OG005
        value
        -2.0
      2. group Id
        OG007
        value
        -19.0
      3. group Id
        OG008
        value
        12.0
      4. group Id
        OG009
        value
        -9.0
    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
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    WEEK 91 DAY 1, 0.25hour Post-Dose
  7. categories
    1. measurements
      1. group Id
        OG005
        value
        -6.0
      2. group Id
        OG007
        value
        -11.0
      3. group Id
        OG008
        value
        11.0
      4. group Id
        OG009
        value
        -19.0
    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
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    WEEK 91 DAY 1, 1hour Post-Dose
  8. categories
    1. measurements
      1. group Id
        OG006
        value
        -5.0
      2. group Id
        OG008
        value
        -14.0
      3. group Id
        OG009
        value
        21.0
      4. group Id
        OG010
        value
        13.0
    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
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    WEEK 94 DAY 1, Predose
  9. categories
    1. measurements
      1. group Id
        OG006
        value
        -4.0
      2. group Id
        OG008
        value
        -22.0
      3. group Id
        OG009
        value
        16.0
      4. group Id
        OG010
        value
        12.0
    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
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    WEEK 94 DAY 1, 0.25hour Post-Dose
  10. categories
    1. measurements
      1. group Id
        OG006
        value
        -4.0
      2. group Id
        OG008
        value
        -28.0
      3. group Id
        OG009
        value
        11.0
      4. group Id
        OG010
        value
        14.0
    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
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    WEEK 94 DAY 1, 1hour Post-Dose
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        -19.0
      2. group Id
        OG002
        value
        -22.0
      3. group Id
        OG003
        spread
        5.13
        value
        8.3
      4. group Id
        OG008
        spread
        8.49
        value
        -6.0
      5. group Id
        OG009
        value
        -12.0
      6. group Id
        OG011
        value
        -9.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        1
      units
      Participants
    title
    WEEK 109 DAY 1, Predose
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        -18.0
      2. group Id
        OG002
        value
        -24.0
      3. group Id
        OG003
        spread
        3.06
        value
        0.3
      4. group Id
        OG008
        spread
        41.72
        value
        10.5
      5. group Id
        OG009
        value
        -16.0
      6. group Id
        OG011
        value
        -8.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        1
      units
      Participants
    title
    WEEK 109 DAY 1, 0.25hour Post-Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      16
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      12
    7. group Id
      OG006
      value
      12
    8. group Id
      OG007
      value
      12
    9. group Id
      OG008
      value
      13
    10. group Id
      OG009
      value
      17
    11. group Id
      OG010
      value
      12
    12. group Id
      OG011
      value
      16
    units
    Participants
description
Pulse rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
    id
    OG000
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
  2. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG001
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
  3. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG002
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
  4. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG003
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
  5. 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
    OG004
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
  6. 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
    OG005
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
  7. 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
    OG006
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
  8. 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
    OG007
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
  9. 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
    OG008
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
  10. 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
    OG009
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
  11. 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
    OG010
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
  12. 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
    OG011
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
param Type
MEAN
population Description
All treated population. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 4.5 years
title
Change From Baseline in Vital Signs : Pulse Rate
type
PRIMARY
unit Of Measure
beats per minute

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