Phase III, Prospective, Open Label, Multicenter, Randomized Trial of Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged >65.
Intermittent courses of Melphalan and Prednisone (MP) have been the first line therapy in
multiple myeloma, for many years.
Advances in systemic and supportive therapy increased remission rates and overall survival,
but multiple myeloma still remains an incurable haematological malignancy. Several
preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed
multiple myeloma with an overall response rate of 30 to 60%.
Due to its activity, Thalidomide will be evaluated in association with MP in a randomized
study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mario Boccadoro, MD
Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
Italy: Ministry of Health