Clinical Trial: Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Zhi-Hong Liu, M.D.

Current Primary Outcome: Complete response rate [ Time Frame: 12 months ]

Complete response rate at 12 months post-transplantation


Original Primary Outcome: The efficacy criteria are the international standards set with consensus of experts in the Tenth International Symposium on Amyloid and Amyloidosis. [ Time Frame: 4 years ]

Current Secondary Outcome: overall response rate [ Time Frame: 12 months ]

overall response rate(ie.,CR + PR) at 12 months post-transplantation


Original Secondary Outcome:

Information By: Nanjing University School of Medicine

Dates:
Date Received: January 3, 2011
Date Started: March 1, 2011
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017