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Sydney 2005: Interim Analysis of the IFM 99-06 Trial on 350 Patients
By Thierry Facon, MD
04.13.05
Dr. Thierry Facon presented interim analysis data from a trial looking at melphalan-prednisone (MP), MP-thalidomide (MP-T), or high dose therapy (melphalan 100, MEL100) in elderly patients (ages 65-70 years). Overall, no toxic deaths were observed among patients treated with MEL100. Hematologic toxicity of MP compared with MP-T was similar. Notably, 36% of patients in these treatment arms had peripheral neuropathy (PN). Incidence of DVT was examined, excluding patients with a history of previous DVT. No toxic deaths were related to DVT. More DVTs were observed in the MP-T treatment arm than other 2 treatment arms. Consequently, neurotoxicity and DVT are concerns in MP-T arm. Complete responses were 3% for MP, 14% for MP-T, and 18% for MEL100. The results of this study suggest that MEL100 is feasible in approximately 2/3 of elderly patients and that MP-T and MEL100 response rates are similar. The Data Safety Monitoring Board (DSMB) agreed that adverse events were what were expected, that there was not an excess of toxic deaths from any treatment, and that OS supported ongoing patient recruitment. The study is ongoing and the second interim analysis will be conducted in approximately 1 year.


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