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NCT03934684 · OUTCOME

Duration of Response (DOR) 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months

What was measured

DOR was defined as the time from first evidence of PR or better as per IMWG-URC to the earliest of PD or death due to any cause for participants with a best response of PR or better. PD: increase of 25% from lowest response value in serum M-component and/or urine M-component and/or only in participants without measurable serum and urine M protein levels: the difference between involved and uninvolved FLC levels and/or only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia. Medians were estimated using the Kaplan-Meier method. Corresponding 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.

Analysis population: Safety analysis set included all enrolled participants who received at least one dose of IP. DOR was calculated only for participants who achieved a best overall response of PR or better.

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)29
Carfilzomib and Dexamethasone (Kd)28

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib, Lenalidomide and Dexamethasone (KRd)NANot reported11.9NAMedian and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.
Carfilzomib and Dexamethasone (Kd)NANot reported12.4NAMedian and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.
        group Id
        OG000
        lower Limit
        11.9
        upper Limit
        NA
        value
        NA
      2. comment
        Median and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.
        group Id
        OG001
        lower Limit
        12.4
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      28
    units
    Participants
description
DOR was defined as the time from first evidence of PR or better as per IMWG-URC to the earliest of PD or death due to any cause for participants with a best response of PR or better. PD: increase of 25% from lowest response value in serum M-component and/or urine M-component and/or only in participants without measurable serum and urine M protein levels: the difference between involved and uninvolved FLC levels and/or only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia. Medians were estimated using the Kaplan-Meier method. Corresponding 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
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
MEDIAN
population Description
Safety analysis set included all enrolled participants who received at least one dose of IP. DOR was calculated only for participants who achieved a best overall response of PR or better.
reporting Status
POSTED
time Frame
From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months
title
Duration of Response (DOR) as Per IMWG-URC
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice