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NCT00114101 · OUTCOME

Overall Survival

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant · Source last updated 2026-08-26

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
Duration of study (up to 10 years)

What was measured

Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.

Groups in this outcome

Lenalidomide Maintenance

Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Placebo Maintenance

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)

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 Maintenance231
Placebo Maintenance229

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide MaintenanceNANot reportedNANAThe median overall survival has not been reached.
Placebo MaintenanceNANot reportedNANAThe median overall survival has not been reached.

Source statistical analyses

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

  1. ci Lower Limit
    0.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.70
    param Type
    Hazard Ratio (HR)
    param Value
    0.52
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.02
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.70
    param Type
    Hazard Ratio (HR)
    param Value
    0.52
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median overall survival has not been reached.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The median overall survival has not been reached.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      231
    2. group Id
      OG001
      value
      229
    units
    Participants
description
Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
    id
    OG000
    title
    Lenalidomide Maintenance
  2. description
    Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day. (closed as of 12/17/09)
    id
    OG001
    title
    Placebo Maintenance
param Type
MEDIAN
reporting Status
POSTED
time Frame
Duration of study (up to 10 years)
title
Overall Survival
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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

Preserved source evidence · Not medical advice