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NCT03848845 · OUTCOME

Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score

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
Days
Interval / dispersion
Full Range
Time frame
Up to approximately 178 weeks

What was measured

The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score \< 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date.

Analysis population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

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 Expansion2

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion34.5Not reported2247Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        47
        value
        34.5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score \< 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date.
dispersion Type
Full Range
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. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Up to approximately 178 weeks
title
Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice