Skip to content
← Full study record

NCT02880228 · OUTCOME

Progression-free Survival

Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant · Source last updated 2019-07-30

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
From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years

What was measured

Progression-free survival is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients who receive subsequent treatment for myeloma before disease progression will be censored on the date of their last disease assessment prior to initiation of the subsequent treatment. Transplant will not be considered subsequent treatment. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

Analysis population: All patients that began protocol treatment were included in this analysis.

Groups in this outcome

Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)

Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.

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

Analysis denominator · Participants

GroupSource count
Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)11

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)NANot reportedNANAToo few events occurred to estimate the median and confidence interval.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Too few events occurred to estimate the median and confidence interval.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Progression-free survival is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients who receive subsequent treatment for myeloma before disease progression will be censored on the date of their last disease assessment prior to initiation of the subsequent treatment. Transplant will not be considered subsequent treatment. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
    id
    OG000
    title
    Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
param Type
MEDIAN
population Description
All patients that began protocol treatment were included in this analysis.
reporting Status
POSTED
time Frame
From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice