Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)
To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]Complete response rate at 12 months post-transplantation
- overall response rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]overall response rate(ie.,CR + PR) at 12 months post-transplantation
- progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]progression-free survival (PFS) at 2 years post-transplantation
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (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. 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
|Contact: Xianghua Huang, Master||0086-025-80860017 ext 210002|
|Suzhou, Jiangsu, China, 215325|
|Contact: Xianghua Huang, Master 0086-025-80860017 ext 210002|
|Principal Investigator: zhihong Liu, Master|
|Principal Investigator:||zhihong Liu, Master||Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China|