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NCT03525678 · OUTCOME

Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
97.5% Confidence Interval
Time frame
Up to 48 weeks

What was measured

ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is \[i.e.\], PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]). Confidence intervals were based on the exact method.

Analysis population: Full Analysis Population comprised of all randomized participants (any participant who received a treatment randomization number was considered as randomized) whether or not randomized treatment was administered. This population was based on the treatment the participant was randomized to.

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)97
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)99
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)25

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 97.5% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)31Not reported20.842.6Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)34Not reported23.946.0Not reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)48Not reported25.571.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.8
        upper Limit
        42.6
        value
        31
      2. group Id
        OG001
        lower Limit
        23.9
        upper Limit
        46.0
        value
        34
      3. group Id
        OG002
        lower Limit
        25.5
        upper Limit
        71.1
        value
        48
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    2. group Id
      OG001
      value
      99
    3. group Id
      OG002
      value
      25
    units
    Participants
description
ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is \[i.e.\], PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]). Confidence intervals were based on the exact method.
dispersion Type
97.5% Confidence Interval
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
NUMBER
population Description
Full Analysis Population comprised of all randomized participants (any participant who received a treatment randomization number was considered as randomized) whether or not randomized treatment was administered. This population was based on the treatment the participant was randomized to.
reporting Status
POSTED
time Frame
Up to 48 weeks
title
Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)
type
PRIMARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice