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NCT02906332 · OUTCOME

Duration of Response (DOR)

Pembrolizumab + Lenalidomide Post Autologous Stem Cell Transplant (ASCT) in High-risk Multiple Myeloma (MM) · Source last updated 2023-08-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Interval between date of first response and date of study completion (through 12 weeks)

What was measured

Assessed by the investigator per International Myeloma Working Group criteria(IMWG) uniform response criteria. Result reflects count of participants who did not have progressive disease at 2 years.

Analysis population: The FDA required enrollment to stop and patients to be removed from treatment due to updated risks of the investigational product. Following removal of the study data was not collected and patients were not analyzed due to this early termination of study intervention.

Groups in this outcome

Pembrolizumab + Lenalidomide

This is an open label study. * Pembrolizumab 200 mg IV every 3 weeks and lenalidomide 25 mg po daily x 14 days and dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles. * This is followed by pembrolizumab 200 mg every 3 weeks and lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for a total of 4 cycles. Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks x 2 cycles. This is followed by followed by pembrolizumab 200 mg IV every 3 weeks for 2 additional cycles. Lenalidomide: Lenalidomide 25 mg po daily x 14 days once weekly for a 21-day cycle x 2 cycles. This is followed by lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for 2 additional cycles. Dexamethasone: Dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles only.

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 + Lenalidomide0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Assessed by the investigator per International Myeloma Working Group criteria(IMWG) uniform response criteria. Result reflects count of participants who did not have progressive disease at 2 years.
groups
  1. description
    This is an open label study. * Pembrolizumab 200 mg IV every 3 weeks and lenalidomide 25 mg po daily x 14 days and dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles. * This is followed by pembrolizumab 200 mg every 3 weeks and lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for a total of 4 cycles. Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks x 2 cycles. This is followed by followed by pembrolizumab 200 mg IV every 3 weeks for 2 additional cycles. Lenalidomide: Lenalidomide 25 mg po daily x 14 days once weekly for a 21-day cycle x 2 cycles. This is followed by lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for 2 additional cycles. Dexamethasone: Dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles only.
    id
    OG000
    title
    Pembrolizumab + Lenalidomide
population Description
The FDA required enrollment to stop and patients to be removed from treatment due to updated risks of the investigational product. Following removal of the study data was not collected and patients were not analyzed due to this early termination of study intervention.
reporting Status
POSTED
time Frame
Interval between date of first response and date of study completion (through 12 weeks)
title
Duration of Response (DOR)
type
SECONDARY

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

Preserved source evidence · Not medical advice