NCT03525678 · OUTCOME

AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03

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

Measure: GEOMETRIC_MEAN
Unit: Hours*microgram per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

What was measured

Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.

Analysis population: Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.

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: GSK2857916 2.5 mg/kg (Frozen Liquid)	95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	99
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	24

Reported measurements

Cycle 1, n=16,10,9

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	16
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	10
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	9

Values in Hours*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	10268	65.8	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	10209	64.9	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	10170	75.0	Not reported	Not reported	Not reported

Cycle 3, n=10,11,3

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	10
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	11
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	3

Values in Hours*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	20526	45.1	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	18637	69.4	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	22782	161.1	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
65.8
value
10268
group Id
OG001
spread
64.9
value
10209
group Id
OG002
spread
75.0
value
10170
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
10
group Id
OG002
value
9
units
Participants
title
Cycle 1, n=16,10,9
categories
measurements
group Id
OG000
spread
45.1
value
20526
group Id
OG001
spread
69.4
value
18637
group Id
OG002
spread
161.1
value
22782
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
11
group Id
OG002
value
3
units
Participants
title
Cycle 3, n=10,11,3

denoms

counts
group Id
OG000
value
95
group Id
OG001
value
99
group Id
OG002
value
24
units
Participants

description

Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
id
OG000
title
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
description
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
id
OG001
title
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
description
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
id
OG002
title
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

param Type

GEOMETRIC_MEAN

population Description

Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

reporting Status

POSTED

time Frame

Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)

title

AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM

type

SECONDARY

unit Of Measure

Hours*microgram per milliliter

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Preserved source evidence · Not medical advice