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Brief Title: Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Official Title: Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.
Study ID: NCT00367185
Brief Summary: In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.
Detailed Description: Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Lille University Hospital, Lille, , France
Name: Jean-Yves MARY
Affiliation: U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France
Role: STUDY_DIRECTOR