Oncology Medical News about multiple myeloma;efficacy of Melphalan;prednisone;plus thalidomide

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Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial
Journal of Clinical Oncology, 05/20/09

Hulin C et al. - In a study to investigate the efficacy of melphalan and prednisone plus thalidomide in pts older than 75 yrs with newly diagnosed myeloma, this trial confirms the superiority of the combination melphalan and prednisone plus thalidomide over melphalan and prednisone alone for prolonging survival in very elderly pts with newly diagnosed myeloma. Toxicity was acceptable.

Methods

232 previously untreated pts with myeloma, age ≥75 yrs, were enrolled and 229 were randomly assigned to treatment.
All pts received melphalan (0.2 mg/kg/d) plus prednisone (2 mg/kg/d) for 12 courses (day 1 to 4) every 6 wks.
Pts were randomly assigned to receive 100 mg/d of oral thalidomide (n = 113) or placebo (n = 116), continuously for 72 wks.
Primary endpoint was overall survival (OS).

Results

After a median follow-up of 47.5 mos, OS was significantly longer in pts who received melphalan and prednisone plus thalidomide vs those who received melphalan and prednisone plus placebo (median, 44.0 vs 29.1 mos).
Progression-free survival was significantly prolonged in the melphalan and prednisone plus thalidomide group (median, 24.1 v 18.5 mos).
2 adverse events were significantly increased in the melphalan and prednisone plus thalidomide group: grade 2 to 4 peripheral neuropathy (20% vs 5% in the melphalan and prednisone plus placebo group) and grade 3 to 4 neutropenia (23% vs 9%).

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