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NCT02576977 · OUTCOME

Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria

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 30 months

What was measured

Progression free survival was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS was assessed by CAC blinded central review according to the IMWG criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The database cutoff date was July 9, 2018.

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+Dexamethasone5.7Not reported4.57.5Not reported
Standard of Care (SOC) Pomalidomide+Dexamethasone7.4Not reported5.611.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.08
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.08
    estimate Comment
    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).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99324
    param Type
    Hazard Ratio (HR)
    param Value
    1.50
    statistical Comment
    One-sided p-value based on Stratified log-rank test.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    1.08
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.08
    estimate Comment
    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).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99324
    param Type
    Hazard Ratio (HR)
    param Value
    1.50
    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
        4.5
        upper Limit
        7.5
        value
        5.7
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        11.5
        value
        7.4
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    2. group Id
      OG001
      value
      125
    units
    Participants
description
Progression free survival was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS was assessed by CAC blinded central review according to the IMWG criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The database cutoff date was July 9, 2018.
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 30 months
title
Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice