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NCT03525678 · OUTCOME

Duration of Response by Independent Review Committee (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
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
Up to 186 weeks

What was measured

DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.

Analysis population: Full Analysis Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis

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)31
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)35
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)13

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)12.5Not reported4.219.4Not reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)6.2Not reported4.2NA\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)9.0Not reported3.410.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        19.4
        value
        12.5
      2. comment
        \<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
        group Id
        OG001
        lower Limit
        4.2
        upper Limit
        NA
        value
        6.2
      3. group Id
        OG002
        lower Limit
        3.4
        upper Limit
        10.4
        value
        9.0
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      35
    3. group Id
      OG002
      value
      13
    units
    Participants
description
DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
dispersion Type
Inter-Quartile 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 Analysis Population. Only responders (confirmed PR or better) by Independent Review Committee were included in this analysis
reporting Status
POSTED
time Frame
Up to 186 weeks
title
Duration of Response by Independent Review Committee (Full Analysis Population)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice