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KOS 2007:Melphalan-Prednisone-Thalidomide (MP-T) is Also Superior to Melphalan-Prednisone (MP) in Patients 75 Years of Age or Older with Untreated Multiple Myeloma (MM). Preliminary Results of the Randomized, Double-Blind, Placebo Controlled IFM 01-01 Trial
Cyrille Hulin, MD
Itergroupe Francophone du Myélome

AUTHORS: C. Hulin, J.M. Virion, V. Coiteux, P. Rodon, B. Pegourie, L. Benboubker, C. Doyen, O. Decaux, M. Dib, G. Guillerm, L. Voillat, L. Gagneux, P. Moreau
Itergroupe Francophone du Myélome

Introduction: The MP-T combination has been shown to be the standard treatment in newly diagnosed MM patients (pts) aged 65 to 75 years (Facon et al; JCO 2006; 24, A1). However, no specific therapeutic recommendation exists for pts older than 75 years regarding the benefit of adding Thalidomide to MP and these pts have frequently been excluded from large clinical trials, although they represent more than 20% of MM pts. Methods: The IFM 01-01 trial was initiated in 04/2002. Patients > 75 years with untreated MM were randomized to receive MP (Melphalan 0.2mg/kg/d + Prednisone 2 mg/kg/d day1-4, 12 courses at 6-weeks intervals) + placebo (MP-placebo) vs MP + daily Thalidomide 100mg/d (MP-T). No anti-VTE prophylaxis was given. The primary end-point was overall survival (OS). Secondary end points were progression-free survival (PFS), response to treatment and toxicity. A first interim analysis was performed after the inclusion of 150 patients and a data safety monitoring board recommended a second analysis after the accrual of 200 patients. We here present the preliminary results of this analysis. Results: At the reference date of November 1, 2006, 232 pts were randomised. In all, 200 pts were analysed (100 per group), with 33.5% of pts >80 years (median age, 78.4 years). There were no differences between the 2 groups regarding baseline characteristics. Data were analysed on an intent-to-treat basis. After the completion of therapy the rates of partial response and very good partial response were 31% and 8% respectively with MP-placebo vs 61% and 22% respectively with MP-T. The median PFS time was 19 months (95%-CI 14.6-21.5) with MP-placebo vs 24.1 months (95%-CI 19.4-29.7) with MP-T (p=0.004 log-rank test). In the MP-T arm, 43/100 pts stopped treatment due to toxicity (10 due to neuropathy) versus 11/100 in the MP-placebo arm. Toxicity (Grade 2-4) included peripheral neuropathy (18%), somnolence (7%) and DVT (7%) with MP-T, vs 6%, 6% and 1% respectively, with MP-placebo. Final results including OS data will be presented at the meeting. Conclusion: MPT is an effective combination with acceptable toxicity in patients with MM older than 75 years of age, with a significant improvement in PFS.

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