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NCT02880228 · OUTCOME

Proportion of Successful Stem Cell Collection

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
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 112 days

What was measured

The proportion of successful stem cell collection following initial therapy with the combination of pembrolizumab, lenalidomide and dexamethasone in patients with newly diagnosed MM will be estimated by the number of patients with a successful stem cell collection divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true successful proportion will be calculated.

Analysis population: Only patients that completed 4 cycles of treatment were eligible for this endpoint.

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)5

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)0.4Not reported0.050.85Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.05
        upper Limit
        0.85
        value
        0.4
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
The proportion of successful stem cell collection following initial therapy with the combination of pembrolizumab, lenalidomide and dexamethasone in patients with newly diagnosed MM will be estimated by the number of patients with a successful stem cell collection divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true successful proportion will be calculated.
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
NUMBER
population Description
Only patients that completed 4 cycles of treatment were eligible for this endpoint.
reporting Status
POSTED
time Frame
Up to 112 days
title
Proportion of Successful Stem Cell Collection
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice