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NCT01239797 · OUTCOME

Median Overall Survival (OS)

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma · Source last updated 2022-06-01

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
Randomization to the date of death from any cause (up to approximately 9 years)

What was measured

Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)

Analysis population: All randomized participants

Groups in this outcome

Lenalidomide + Dexamethasone + Elotuzumab

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide + Dexamethasone

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

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 + Dexamethasone + Elotuzumab321
Lenalidomide + Dexamethasone325

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone + Elotuzumab48.30Not reported40.3451.94Not reported
Lenalidomide + Dexamethasone39.62Not reported33.2545.27Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.34
        upper Limit
        51.94
        value
        48.30
      2. group Id
        OG001
        lower Limit
        33.25
        upper Limit
        45.27
        value
        39.62
denoms
  1. counts
    1. group Id
      OG000
      value
      321
    2. group Id
      OG001
      value
      325
    units
    Participants
description
Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
    id
    OG000
    title
    Lenalidomide + Dexamethasone + Elotuzumab
  2. description
    Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    id
    OG001
    title
    Lenalidomide + Dexamethasone
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
Randomization to the date of death from any cause (up to approximately 9 years)
title
Median Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice