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NCT02289222 · OUTCOME

Time to Progression Free Survival (PFS)

1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-05

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
PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.

What was measured

PFS will be measured in all participants. Survival and PFS functions were estimated using the Kaplan-Meier method. The Cox regression model was used to assess the following plausible risk factors for OS and PFS: age, isotype, number of cycles of therapy, and cytogenetic profile.

Groups in this outcome

Pomalidomide, Dexamethasone & MK-3475

Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14). MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks. Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days Dexamethasone: Dexamethasone is given at 40 mg orally weekly

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

Analysis denominator · Participants

GroupSource count
Pomalidomide, Dexamethasone & MK-347548

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pomalidomide, Dexamethasone & MK-347517.4Not reported11.718.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.7
        upper Limit
        18.8
        value
        17.4
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
PFS will be measured in all participants. Survival and PFS functions were estimated using the Kaplan-Meier method. The Cox regression model was used to assess the following plausible risk factors for OS and PFS: age, isotype, number of cycles of therapy, and cytogenetic profile.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14). MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks. Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days Dexamethasone: Dexamethasone is given at 40 mg orally weekly
    id
    OG000
    title
    Pomalidomide, Dexamethasone & MK-3475
param Type
MEDIAN
reporting Status
POSTED
time Frame
PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.
title
Time to Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice