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NCT03525678 · OUTCOME

Overall Response Rate by Independent Review Committee (Efficacy 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
95% Confidence Interval
Time frame
Up to 48 weeks

What was measured

ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.

Analysis population: Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.

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.

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)64
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)66

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)30Not reported18.942.4Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)30Not reported19.642.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.9
        upper Limit
        42.4
        value
        30
      2. group Id
        OG001
        lower Limit
        19.6
        upper Limit
        42.9
        value
        30
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    2. group Id
      OG001
      value
      66
    units
    Participants
description
ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.
dispersion Type
95% 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)
param Type
NUMBER
population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
reporting Status
POSTED
time Frame
Up to 48 weeks
title
Overall Response Rate by Independent Review Committee (Efficacy Population)
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice