Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL|
- Complete response rate [ Time Frame: 12 months ]Complete response rate at 12 months post-transplantation
- overall response rate [ Time Frame: 12 months ]overall response rate(ie.,CR + PR) at 12 months post-transplantation
- progression-free survival [ Time Frame: 2 years ]progression-free survival (PFS) at 2 years post-transplantation
|Actual Study Start Date:||March 1, 2011|
|Study Completion Date:||May 12, 2016|
|Primary Completion Date:||May 12, 2016 (Final data collection date for primary outcome measure)|
Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4.
Other Name: autologous hematopoietic stem cell transplantation
Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4. After two cycles of vel / dex therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4 weeks.Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients ) and Vel 1mg/m2 (days -6, -3, +1, +4) will be given. Four additional 21-day cycles of Vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the cycle) will be conducted as consolidation therapy during the recommended 60-90 days after HSCT, or after resumption of hematopoietic function ( neutrophil count > 1.5x109/L and platelet count> 50x109/L). Later patients won't need maintenance therapy.
The efficacy criteria are the international standards set with consensus of experts in the Tenth International Symposium on Amyloid and Amyloidosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273844
|Suzhou, Jiangsu, China, 215325|
|Principal Investigator:||zhihong Liu, Master||Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China|