Superiority of melphalan-prednisone (MP) + thalidomide (THAL) over MP or autologous stem cell transplantation in the treatment of newly diagnosed elderly patients with multiple myeloma (MM)

Reviewer: Charles Wood, MD
Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 5, 2006

Presenter: Facon T
Presenter's Affiliation: CHU, Lille, France
Type of Session: Plenary

Background

  • MP is the standard treatment for newly diagnosed elderly patients with MM, conferring a median overall survival (OS) of 3 years
  • THAL has demonstrated activity in relapsed MM, and is currently being used with MP as well as stem cell replantation
  • MELP has been shown to provide an OS advantage in MM in the 65-75 year patient age group
  • In May 2000, the IFM 99-06 trial was initiated to compare MP with MP-THAL as well as MEL-100 (intermediate-dose chemotherapy supported by stem cell replantation)

Materials and Methods

  • This was a phase III multicenter randomized trial designed to compare MP and MP-THAL as well as MP and MEL-100
  • The primary endpoint was OS, and secondary endpoints included response to treatment and progression-free survival (PFS)
  • Patients were stratified by treatment center and randomized to MP, MP-THAL, or MEL-100 in a 3:2:2 schema, respectively
  • The MP arm consisted of 12 courses at 6 week intervals
  • The MP-THAL arm consist of MP plus THAL at the maximum tolerated dose, but less than or equal to 400 mg/day
  • The MEL-100 arm consisted of VAD x 2, cyclophosphamide 3 g/m 2 , and 2 courses of MEL-100 mg/m 2 + granulocyte support + peripheral stem cell rescue; Clodronate was given to all patients
  • 2 interim analyses were planned by an independent group, and at the conclusion of the second interim analysis, a third interim analysis was recommended

Results

  • the median follow-up was 37 months
  • 436 patients were enrolled and randomized to MP (n=191), MP-THAL (n=124), and MEL-100 (121)
  • Between the 2 groups, 41% of patients were over 70 years of age, the majority of patients had IgG disease (64%), 61% had beta-2 microglobulin greater than or equal to 3.5, 25% had albumins less than 3.5, 49% had deletion of chromosome 13, and 7% had creatinines greater than 2.0
  • Comparison of OS between groups:
 

MP

MP-THAL

MEL-100

p

OS (months)

32.2±4.2

53.6±5.2

38.6±3.4

significant (MP-THAL vs. MP)

significant (MP-THAL vs. MEL-100)

NS (MP vs

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