The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Divisionedi Ematologia - Ospedali Riuniti
Bergamo, Italy
Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna
Bologna, Italy
Divisione di Ematologia - Az. Osp. S.Croce Carle
Response Rate
Progression Free Survival
Event Free Survival
Safety
Overall Survival
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Cuneo, Italy
U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza
Foggia, Italy
Ematologia - H.S. Gerardo
Monza, Italy
Cattedra e Divisione di Ematologia Università Federico II
Naples, Italy
Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello
Palermo, Italy
Clinica Medica I, Policlinico Monteluce
Perugia, Italy
Divisione di Ematologia Ospedali Riuniti
Reggio Calabria, Italy
Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio
Roma, Italy
...and 3 more locations