NCT03525678 · OUTCOME

AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 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*nanogram 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 Cys-mcMMAF 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=27,20,19

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	27
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	20
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	19

Values in Hours*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	79.26	61.0	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	113.57	58.3	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	100.35	51.8	Not reported	Not reported	Not reported

Cycle 3, n=26,29,11

Analysis denominator · Participants

Group	Source count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	26
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	29
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	11

Values in Hours*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)	70.84	46.9	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)	74.04	73.0	Not reported	Not reported	Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)	69.83	36.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
61.0
value
79.26
group Id
OG001
spread
58.3
value
113.57
group Id
OG002
spread
51.8
value
100.35
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
20
group Id
OG002
value
19
units
Participants
title
Cycle 1, n=27,20,19
categories
measurements
group Id
OG000
spread
46.9
value
70.84
group Id
OG001
spread
73.0
value
74.04
group Id
OG002
spread
36.6
value
69.83
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
29
group Id
OG002
value
11
units
Participants
title
Cycle 3, n=26,29,11

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 Cys-mcMMAF 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-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM

type

SECONDARY

unit Of Measure

Hours*nanogram per milliliter

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Preserved source evidence · Not medical advice