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NCT01169337 · OUTCOME

2-year Overall Survival (OS) Rate (Phase III Secondary Endpoint)

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma · Source last updated 2026-08-04

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 3 months for 2 years

What was measured

Overall survival is defined as the time from randomization to death or date last known alive among all randomized patients in the phase III part of the study. Kaplan-Meier method was used to estimate the 2-year OS rate.

Analysis population: All randomized patients in the phase III part of the study

Groups in this outcome

Arm A (Lenalidomide; Phase III)

Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm B (Observation; Phase III)

Patients undergo observation until progression to symptomatic myeloma.

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

Analysis denominator · Participants

GroupSource count
Arm A (Lenalidomide; Phase III)90
Arm B (Observation; Phase III)92

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Lenalidomide; Phase III)0.98Not reported0.951.00Not reported
Arm B (Observation; Phase III)1.00Not reported1.001.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.95
        upper Limit
        1.00
        value
        0.98
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        1.00
        value
        1.00
denoms
  1. counts
    1. group Id
      OG000
      value
      90
    2. group Id
      OG001
      value
      92
    units
    Participants
description
Overall survival is defined as the time from randomization to death or date last known alive among all randomized patients in the phase III part of the study. Kaplan-Meier method was used to estimate the 2-year OS rate.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm A (Lenalidomide; Phase III)
  2. description
    Patients undergo observation until progression to symptomatic myeloma.
    id
    OG001
    title
    Arm B (Observation; Phase III)
param Type
NUMBER
population Description
All randomized patients in the phase III part of the study
reporting Status
POSTED
time Frame
Assessed every 3 months for 2 years
title
2-year Overall Survival (OS) Rate (Phase III Secondary Endpoint)
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice