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NCT00644228 · OUTCOME

Progression-free Survival

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma · Source last updated 2026-07-29

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 date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years

What was measured

Unstratified median progression-free survival in months.

Analysis population: All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.

Groups in this outcome

Arm I (Dexamethasone and Lenalidomide)

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO

Arm II (Dexamethasone, Lenalidomide, Bortezomib)

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO

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 I (Dexamethasone and Lenalidomide)229
Arm II (Dexamethasone, Lenalidomide, Bortezomib)242

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Dexamethasone and Lenalidomide)30Not reported2939Not reported
Arm II (Dexamethasone, Lenalidomide, Bortezomib)43Not reported3952Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.560
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    96
    ci Upper Limit
    0.906
    estimate Comment
    The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.
    group Description
    With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0018
    p Value Comment
    The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).
    param Type
    Hazard Ratio (HR)
    param Value
    0.712
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.560
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    96
    ci Upper Limit
    0.906
    estimate Comment
    The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.
    group Description
    With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0018
    p Value Comment
    The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).
    param Type
    Hazard Ratio (HR)
    param Value
    0.712
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29
        upper Limit
        39
        value
        30
      2. group Id
        OG001
        lower Limit
        39
        upper Limit
        52
        value
        43
denoms
  1. counts
    1. group Id
      OG000
      value
      229
    2. group Id
      OG001
      value
      242
    units
    Participants
description
Unstratified median progression-free survival in months.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    OG000
    title
    Arm I (Dexamethasone and Lenalidomide)
  2. description
    Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    OG001
    title
    Arm II (Dexamethasone, Lenalidomide, Bortezomib)
param Type
MEDIAN
population Description
All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.
reporting Status
POSTED
time Frame
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years
title
Progression-free Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice