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NCT00602641 · OUTCOME

Progression-Free Survival (PFS)

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2026-08-28

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
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

What was measured

PFS is defined as the time from randomization to the earlier of progression or death of any cause.

Analysis population: Intention-to-treat (ITT) population

Groups in this outcome

Arm I (MPT-T)

Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.

Arm II (mPR-R)

Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.

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 (MPT-T)154
Arm II (mPR-R)152

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (MPT-T)21.0Not reported18.227.5Not reported
Arm II (mPR-R)18.7Not reported16.022.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.045
    estimate Comment
    Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.
    group Description
    Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
Complete source fields
analyses
  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.045
    estimate Comment
    Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.
    group Description
    Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.2
        upper Limit
        27.5
        value
        21.0
      2. group Id
        OG001
        lower Limit
        16.0
        upper Limit
        22.1
        value
        18.7
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      152
    units
    Participants
description
PFS is defined as the time from randomization to the earlier of progression or death of any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.
    id
    OG000
    title
    Arm I (MPT-T)
  2. description
    Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.
    id
    OG001
    title
    Arm II (mPR-R)
param Type
MEDIAN
population Description
Intention-to-treat (ITT) population
reporting Status
POSTED
time Frame
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
title
Progression-Free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice