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NCT01335399 · OUTCOME

Progression-Free Survival (PFS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

What was measured

PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld Cohort31.38Not reported26.1836.80Not reported
Ld Cohort29.47Not reported23.4934.30Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4358
    statistical Method
    Stratified Log Rank
  2. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.71
    ci Upper Limit
    1.12
    estimate Comment
    E-Ld/Ld. Calculated using Cox proportional hazards modeling
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4358
    statistical Method
    Stratified Log Rank
  2. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.71
    ci Upper Limit
    1.12
    estimate Comment
    E-Ld/Ld. Calculated using Cox proportional hazards modeling
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.18
        upper Limit
        36.80
        value
        31.38
      2. group Id
        OG001
        lower Limit
        23.49
        upper Limit
        34.30
        value
        29.47
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      374
    units
    Participants
description
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization
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
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
title
Progression-Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice