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NCT02576977 · OUTCOME

Overall Survival (OS)

Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183) · Source last updated 2021-10-08

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 54 months

What was measured

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Median overall survival was calculated from the product-limit (Kaplan-Meier) method for censored data. The database cutoff date was August 3, 2020.

Analysis population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Pembrolizumab+Pomalidomide+Dexamethasone

Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

Standard of Care (SOC) Pomalidomide+Dexamethasone

Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab+Pomalidomide+Dexamethasone126
Standard of Care (SOC) Pomalidomide+Dexamethasone125

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab+Pomalidomide+Dexamethasone21.0Not reported14.229.1Not reported
Standard of Care (SOC) Pomalidomide+Dexamethasone39.6Not reported28.5NAOS upper limit was not reached due to an insufficient number of deaths.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.55
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).
    p Value
    0.99989
    param Type
    Hazard Ratio (HR)
    param Value
    1.84
    statistical Comment
    One-sided p-value based on Stratified log-rank test.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    1.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.55
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).
    p Value
    0.99989
    param Type
    Hazard Ratio (HR)
    param Value
    1.84
    statistical Comment
    One-sided p-value based on Stratified log-rank test.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.2
        upper Limit
        29.1
        value
        21.0
      2. comment
        OS upper limit was not reached due to an insufficient number of deaths.
        group Id
        OG001
        lower Limit
        28.5
        upper Limit
        NA
        value
        39.6
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    2. group Id
      OG001
      value
      125
    units
    Participants
description
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Median overall survival was calculated from the product-limit (Kaplan-Meier) method for censored data. The database cutoff date was August 3, 2020.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    Pembrolizumab+Pomalidomide+Dexamethasone
  2. description
    Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    OG001
    title
    Standard of Care (SOC) Pomalidomide+Dexamethasone
param Type
MEDIAN
population Description
The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
reporting Status
POSTED
time Frame
Up to approximately 54 months
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice