Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma (Flu-Mel-Vel)
|Multiple Myeloma||Drug: Fludarabine monophosphate, melphalan, Bortezomib||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib|
- Progression free survival [ Time Frame: 2 years ]The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur.
|Actual Study Start Date:||June 9, 2010|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2019 (Final data collection date for primary outcome measure)|
|Fludarabine, Melphalan, Bortezomib||
Drug: Fludarabine monophosphate, melphalan, Bortezomib
Multiple myeloma is the second most prevalent blood cancer (10%) after non-hodgkin's lymphoma. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although the peak age of onset of multiple myeloma is 70 years of age, recent statistics indicate both increasing incidence and earlier age of onset.
The historical control 2-year progression-free survival (PFS) is assumed to be 35%. The proposed therapy of fludarabine, melphalan and bortezomib is expected to improve the PFS by 20%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453101
|United States, New Jersey|
|John Theurer Cancer Center at Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|