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NCT03848845 · OUTCOME

Part 2 - Time to Disease Progression

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 178 weeks

What was measured

Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).

Analysis population: All Treated Population

Groups in this outcome

Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

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 Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion28

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion2.5Not reported0.85.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        5.6
        value
        2.5
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
    id
    OG000
    title
    Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
param Type
MEDIAN
population Description
All Treated Population
reporting Status
POSTED
time Frame
Up to approximately 178 weeks
title
Part 2 - Time to Disease Progression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice