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NCT02036502 · OUTCOME

Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment

A Study of Pembrolizumab (MK-3475) in Combination With Standard of Care Treatments in Participants With Multiple Myeloma (MK-3475-023/KEYNOTE-023) · Source last updated 2021-04-08

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 72.7 months

What was measured

PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause. PD= ≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas. The median PFS was calculated from the Kaplan-Meier method for censored data.

Analysis population: The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.

Groups in this outcome

Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg

Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).

Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg

Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).

Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg

Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).

Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg

Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).

Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg

Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).

Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg

Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.

Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg

Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.

Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg

Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.

Pooled rrMM Cohort

Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.

Pooled rMM Cohort

Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during 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
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg0
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg0
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg0
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg0
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg0
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg0
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg0
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg0
Pooled rrMM Cohort63
Pooled rMM Cohort10

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pooled rrMM Cohort5.6Not reported2.87.2Not reported
Pooled rMM Cohort14.3Not reported2.019.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG008
        lower Limit
        2.8
        upper Limit
        7.2
        value
        5.6
      2. group Id
        OG009
        lower Limit
        2.0
        upper Limit
        19.6
        value
        14.3
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      63
    10. group Id
      OG009
      value
      10
    units
    Participants
description
PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause. PD= ≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas. The median PFS was calculated from the Kaplan-Meier method for censored data.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
    id
    OG000
    title
    Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
  2. description
    Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
    id
    OG001
    title
    Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
  3. description
    Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
    id
    OG002
    title
    Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
  4. description
    Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
    id
    OG003
    title
    Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
  5. description
    Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
    id
    OG004
    title
    Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
  6. description
    Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
    id
    OG005
    title
    Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
  7. description
    Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
    id
    OG006
    title
    Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
  8. description
    Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
    id
    OG007
    title
    Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
  9. description
    Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
    id
    OG008
    title
    Pooled rrMM Cohort
  10. description
    Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
    id
    OG009
    title
    Pooled rMM Cohort
param Type
MEDIAN
population Description
The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
reporting Status
POSTED
time Frame
Up to approximately 72.7 months
title
Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
type
OTHER_PRE_SPECIFIED
unit Of Measure
Months

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Preserved source evidence · Not medical advice