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.
N/A
N/A
Both
Multiple Myeloma
Trial Information
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.
Inclusion Criteria:
- untreated myeloma patients
- age >65 years of age or younger but excluded from transplant procedure
- Durie & Salmon stage II or III myeloma and measurable disease.
- Patients agreed to use contraception
Exclusion Criteria:
- other cancer
- psychiatric disease and any grade 2 peripheral neuropathy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate
Principal Investigator
Mario Boccadoro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy
Authority:
Italy: Ministry of Health
Study ID:
GISMM2001-A
NCT ID:
NCT00232934
Start Date:
January 2002
Completion Date:
May 2010
Related Keywords:
- Multiple Myeloma
- Myeloma
- Thalidomide
- Diagnosis
- Elderly patients
- Multiple Myeloma
- Neoplasms, Plasma Cell
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