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NCT03934684 · OUTCOME

Clinical Benefit Rate (CBR) as Per IMWG-URC

Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma · Source last updated 2026-05-11

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
95% Confidence Interval
Time frame
From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months

What was measured

CBR was defined as the percentage of participants with either the best overall response of sCR, CR, VGPR, PR, and minimal response (MR) as determined by the IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in BM. sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. MR: ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50% to 89%. The CBR 95% CIs were estimated using the Clopper-Pearson method.

Analysis population: Safety analysis set included all enrolled participants who received at least one dose of IP.

Groups in this outcome

Carfilzomib, Lenalidomide and Dexamethasone (KRd)

Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.

Carfilzomib and Dexamethasone (Kd)

Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-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
Carfilzomib, Lenalidomide and Dexamethasone (KRd)49
Carfilzomib and Dexamethasone (Kd)52

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib, Lenalidomide and Dexamethasone (KRd)63.3Not reported48.376.6Not reported
Carfilzomib and Dexamethasone (Kd)57.7Not reported43.271.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.3
        upper Limit
        76.6
        value
        63.3
      2. group Id
        OG001
        lower Limit
        43.2
        upper Limit
        71.3
        value
        57.7
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      52
    units
    Participants
description
CBR was defined as the percentage of participants with either the best overall response of sCR, CR, VGPR, PR, and minimal response (MR) as determined by the IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in BM. sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. MR: ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50% to 89%. The CBR 95% CIs were estimated using the Clopper-Pearson method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.
    id
    OG000
    title
    Carfilzomib, Lenalidomide and Dexamethasone (KRd)
  2. description
    Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
    id
    OG001
    title
    Carfilzomib and Dexamethasone (Kd)
param Type
NUMBER
population Description
Safety analysis set included all enrolled participants who received at least one dose of IP.
reporting Status
POSTED
time Frame
From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months
title
Clinical Benefit Rate (CBR) as Per IMWG-URC
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice