Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years
- Conditions
- Newly Diagnosed Myeloma Patient Above 65 Years Old
- Registration Number
- NCT01671826
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- Brief Summary
Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.
- Detailed Description
Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade庐) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 55
- newly diagnosed MM,
- age over 65,
- measurable disease
- Patients less than 65 and/or not proceeding to autologous PBSC transplantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free survival 2 years
- Secondary Outcome Measures
Name Time Method Time To Progression 2 years Overall Survival 2 years Response after induction, 3 months post transplant, 2 months post consolidation
Trial Locations
- Locations (3)
Institut Paoli Calmette
馃嚝馃嚪Marseille, France
CHU
馃嚝馃嚪Nantes, France
H么pital Saint Antoine
馃嚝馃嚪Paris, France