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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 400
- Locations
- 26
- Primary Endpoint
- Response Rate
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Response Rate
Event Free Survival
Progression Free Survival
Secondary Outcomes
- Overall Survival
- Safety