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NCT04191616 · OUTCOME

Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC

Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet · Source last updated 2025-09-04

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

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks

What was measured

Disease response and progression were determined using IMWG-URC. Durations were calculated for responders. Medians and percentiles were estimated using the Kaplan-Meier method. 90% CIs for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.

Analysis population: The safety analysis set included all participants who received at least 1 dose of carfilzomib. Only participants who achieved a partial response or better were included in the analysis.

Groups in this outcome

Carfilzomib With Pomalidomide and Dexamethasone (KPd)

Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib With Pomalidomide and Dexamethasone (KPd)30

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib With Pomalidomide and Dexamethasone (KPd)20.3Not reported9.2NAUpper confidence interval (CI) is N/A because it was not estimable due to data structure. Not enough events occurred at later times for reliable upper CI to be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper confidence interval (CI) is N/A because it was not estimable due to data structure. Not enough events occurred at later times for reliable upper CI to be calculated.
        group Id
        OG000
        lower Limit
        9.2
        upper Limit
        NA
        value
        20.3
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Disease response and progression were determined using IMWG-URC. Durations were calculated for responders. Medians and percentiles were estimated using the Kaplan-Meier method. 90% CIs for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
dispersion Type
90% Confidence Interval
groups
  1. description
    Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
    id
    OG000
    title
    Carfilzomib With Pomalidomide and Dexamethasone (KPd)
param Type
MEDIAN
population Description
The safety analysis set included all participants who received at least 1 dose of carfilzomib. Only participants who achieved a partial response or better were included in the analysis.
reporting Status
POSTED
time Frame
From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
title
Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice