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NCT03525678 · OUTCOME

Tmax of 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
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
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

GroupSource 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

GroupSource 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 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)22.830Not reported1.9265.63Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)23.835Not reported17.3872.65Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24.080Not reported0.9769.47Not reported
Cycle 3, n=26,29,11

Analysis denominator · Participants

GroupSource 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 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)23.235Not reported0.5846.08Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)22.570Not reported0.5570.98Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)22.780Not reported0.5071.93Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.92
        upper Limit
        65.63
        value
        22.830
      2. group Id
        OG001
        lower Limit
        17.38
        upper Limit
        72.65
        value
        23.835
      3. group Id
        OG002
        lower Limit
        0.97
        upper Limit
        69.47
        value
        24.080
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        19
      units
      Participants
    title
    Cycle 1, n=27,20,19
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.58
        upper Limit
        46.08
        value
        23.235
      2. group Id
        OG001
        lower Limit
        0.55
        upper Limit
        70.98
        value
        22.570
      3. group Id
        OG002
        lower Limit
        0.50
        upper Limit
        71.93
        value
        22.780
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        29
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Cycle 3, n=26,29,11
denoms
  1. counts
    1. group Id
      OG000
      value
      95
    2. group Id
      OG001
      value
      99
    3. 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
Full Range
groups
  1. 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)
  2. 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)
  3. 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
MEDIAN
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
Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
type
SECONDARY
unit Of Measure
Hours

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Preserved source evidence · Not medical advice