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NCT01953692 · OUTCOME

Stringent Complete Remission (sCR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013) · Source last updated 2021-08-04

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

Measure
NUMBER
Unit
Percentage of partiicpants
Interval / dispersion
90% Confidence Interval
Time frame
Up to approximately 78.5 months

What was measured

sCR was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. sCR was defined as complete response \[CR\] plus normal serum free light-chain ratio and absence of clonal cells in bone marrow. CR criteria are negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and ≤5% plasma cells in the bone marrow. The percentage of participants with sCR as assessed by the investigator is presented.

Analysis population: All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.

Groups in this outcome

Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-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
Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)30

Reported measurements

Source class 1
Values in Percentage of partiicpants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)0.0Not reported0.09.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        9.5
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
sCR was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. sCR was defined as complete response \[CR\] plus normal serum free light-chain ratio and absence of clonal cells in bone marrow. CR criteria are negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and ≤5% plasma cells in the bone marrow. The percentage of participants with sCR as assessed by the investigator is presented.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    OG000
    title
    Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
param Type
NUMBER
population Description
All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
reporting Status
POSTED
time Frame
Up to approximately 78.5 months
title
Stringent Complete Remission (sCR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
type
SECONDARY
unit Of Measure
Percentage of partiicpants

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

Preserved source evidence · Not medical advice