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NCT03361306 · OUTCOME

Duration of Response (DoR)

LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma · Source last updated 2026-03-06

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 time of first response to date of progression/death, or censored as described; assessed for approximately 3 years.

What was measured

DoR will be calculated for each subject with a partial response, very good partial response, complete response, or stringent complete response on study treatment. The DoR intervals will be calculated from the time of the first assessment that identified response until disease progression or death. The censoring mechanism for DoR will be the same as described for PFS.

Analysis population: The analysis population consisted of all subjects who initiated Elo-KRd and achieved a PR or better during study treatment.

Groups in this outcome

KRd-Elotuzumab

Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)

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

Analysis denominator · Participants

GroupSource count
KRd-Elotuzumab12

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
KRd-Elotuzumab13.3Not reported1.833.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    33.0
    estimate Comment
    The Kaplan Meier method was used to estimate median DoR (in months). The Greenwood method was used to estimate confidence limits of median duration on response.
    group Ids
    1. OG000
    non Inferiority Comment
    Estimation only
    non Inferiority Type
    OTHER
    param Type
    Median
    param Value
    13.3
Complete source fields
analyses
  1. ci Lower Limit
    1.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    33.0
    estimate Comment
    The Kaplan Meier method was used to estimate median DoR (in months). The Greenwood method was used to estimate confidence limits of median duration on response.
    group Ids
    1. OG000
    non Inferiority Comment
    Estimation only
    non Inferiority Type
    OTHER
    param Type
    Median
    param Value
    13.3
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        33.0
        value
        13.3
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
DoR will be calculated for each subject with a partial response, very good partial response, complete response, or stringent complete response on study treatment. The DoR intervals will be calculated from the time of the first assessment that identified response until disease progression or death. The censoring mechanism for DoR will be the same as described for PFS.
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
    id
    OG000
    title
    KRd-Elotuzumab
param Type
MEDIAN
population Description
The analysis population consisted of all subjects who initiated Elo-KRd and achieved a PR or better during study treatment.
reporting Status
POSTED
time Frame
From time of first response to date of progression/death, or censored as described; assessed for approximately 3 years.
title
Duration of Response (DoR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice