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NCT04191616 · OUTCOME

Overall Response Rate (ORR) As Assessed by the Independent Review Committee (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
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks

What was measured

Overall response was defined as the best overall confirmed response of: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Assessment was by IRC per International Myeloma Working Group Uniform Response Criteria (IMWG-URC). The 90% confidence intervals were estimated using the Clopper-Pearson method (1994).

Analysis population: The safety analysis set included all participants who received at least 1 dose of carfilzomib.

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)52

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib With Pomalidomide and Dexamethasone (KPd)57.7Not reported45.469.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.4
        upper Limit
        69.3
        value
        57.7
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
Overall response was defined as the best overall confirmed response of: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Assessment was by IRC per International Myeloma Working Group Uniform Response Criteria (IMWG-URC). The 90% confidence intervals were estimated using the Clopper-Pearson method (1994).
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
NUMBER
population Description
The safety analysis set included all participants who received at least 1 dose of carfilzomib.
reporting Status
POSTED
time Frame
From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks
title
Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice