NCT03544281 · OUTCOME

AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment B

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: h*ug/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

What was measured

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

Analysis population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

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

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

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

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

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

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

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

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex	8
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex	6
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	4
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex	6
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex	8
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex	12
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex	7
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex	11

Reported measurements

Source class 1

Values in h*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex	7310.17	37.27	Not reported	Not reported	Not reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex	6094.55	33.37	Not reported	Not reported	Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex	8386.87	25.44	Not reported	Not reported	Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex	9891.43	29.93	Not reported	Not reported	Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex	8283.76	32.51	Not reported	Not reported	Not reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex	8207.69	41.72	Not reported	Not reported	Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex	9812.19	27.13	Not reported	Not reported	Not reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex	12581.08	28.13	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
37.27
value
7310.17
group Id
OG001
spread
33.37
value
6094.55
group Id
OG002
spread
25.44
value
8386.87
group Id
OG003
spread
29.93
value
9891.43
group Id
OG004
spread
32.51
value
8283.76
group Id
OG005
spread
41.72
value
8207.69
group Id
OG006
spread
27.13
value
9812.19
group Id
OG007
spread
28.13
value
12581.08

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
6
group Id
OG002
value
4
group Id
OG003
value
6
group Id
OG004
value
8
group Id
OG005
value
12
group Id
OG006
value
7
group Id
OG007
value
11
units
Participants

description

Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.

dispersion Type

Geometric Coefficient of Variation

groups

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
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
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
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
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
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
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
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

GEOMETRIC_MEAN

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, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

title

AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment B

type

SECONDARY

unit Of Measure

h*ug/mL

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Preserved source evidence · Not medical advice