Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01080391 · OUTCOME

Duration of Response

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma · Source last updated 2022-09-21

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 randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.

What was measured

Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.

Analysis population: The Intent to treat (ITT) population with participantant who achieved a best overall response of PR or better.

Groups in this outcome

Lenalidomide and Dexamethasone (Rd)

Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.

Carfilzomib, Lenalidomide, and Dexamethasone (CRd)

Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every 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
Lenalidomide and Dexamethasone (Rd)264
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)345

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone (Rd)21.2Not reported16.725.8Not reported
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)28.6Not reported24.931.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.7
        upper Limit
        25.8
        value
        21.2
      2. group Id
        OG001
        lower Limit
        24.9
        upper Limit
        31.3
        value
        28.6
denoms
  1. counts
    1. group Id
      OG000
      value
      264
    2. group Id
      OG001
      value
      345
    units
    Participants
description
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
    id
    OG000
    title
    Lenalidomide and Dexamethasone (Rd)
  2. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
    id
    OG001
    title
    Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
param Type
MEDIAN
population Description
The Intent to treat (ITT) population with participantant who achieved a best overall response of PR or better.
reporting Status
POSTED
time Frame
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
title
Duration of Response
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice