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NCT01335399 · OUTCOME

Objective Response Rate (ORR)

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2022-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percent of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to primary completion date (approximately 8 years)

What was measured

ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.

Analysis population: All randomized participants

Groups in this outcome

E-Ld Cohort

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Ld Cohort

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 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
E-Ld Cohort374
Ld Cohort374

Reported measurements

Source class 1
Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld Cohort82.9Not reported78.786.6Not reported
Ld Cohort79.4Not reported75.083.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.82
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2232
    param Type
    CMH ESTIMATE OF COMMON ODDS RATIO
    param Value
    1.26
    statistical Method
    CMH ESTIMATE OF COMMON ODDS RATIO
Complete source fields
analyses
  1. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.82
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2232
    param Type
    CMH ESTIMATE OF COMMON ODDS RATIO
    param Value
    1.26
    statistical Method
    CMH ESTIMATE OF COMMON ODDS RATIO
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.7
        upper Limit
        86.6
        value
        82.9
      2. group Id
        OG001
        lower Limit
        75.0
        upper Limit
        83.4
        value
        79.4
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      374
    units
    Participants
description
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG000
    title
    E-Ld Cohort
  2. description
    Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG001
    title
    Ld Cohort
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to primary completion date (approximately 8 years)
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percent of Participants

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

Preserved source evidence · Not medical advice