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NCT02064387 · OUTCOME

ORR-Part 2 (MM)

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)

What was measured

ORR was determined by the investigator according to IMWG 2011 uniform response criteria for MM. ORR was calculated as the number of participants with best overall response of sCR, CR, VGPR and PR.

Analysis population: Part 2 MM Population

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (MM)

Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)35

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
ORR was determined by the investigator according to IMWG 2011 uniform response criteria for MM. ORR was calculated as the number of participants with best overall response of sCR, CR, VGPR and PR.
groups
  1. description
    Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
    id
    OG000
    title
    Part 2: GSK2857916 3.40 mg/kg (MM)
param Type
COUNT_OF_PARTICIPANTS
population Description
Part 2 MM Population
reporting Status
POSTED
time Frame
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)
title
ORR-Part 2 (MM)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice