Clinical Trial: Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Induction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL Amyl
Brief Summary: This randomized phase III trial is studying the side effects and how well giving induction therapy with bortezomib and dexamethasone followed by autologous stem cell transplantation (ASCT) compared with ASCT alone in treating patients with newly diagnosed renal AL amyloidosis. In this prospective, randomized control study, patients with newly diagnosed AL amyloidosis who met the criteria for ASCT were randomized to receive 2 cycles of BD as induction therapy followed by ASCT (BD+ASCT) (arm 1) or to receive ASCT alone as an initial treatment (arm 2). Hematologic and organ responses were evaluated every 3 months after ASCT. All the patients should be followed up for 12 months.
Detailed Summary:
Arm 1: The BD regimen included bortezomib 1.3 mg/m2 i.v. and dexamethasone 40 mg p.o. on days 1, 4, 8 and 11 of the 21 day cycle. This process was repeated for 2 cycles. After two cycles of BD therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4 weeks. Recommended dose of drug is as follows: granulocyte colony-stimulating factor (G-CSF) 5-10ug/kg on days 1-5 will be given, then peripheral blood stem cells will be collected on days 5-6 for 2×10^6 CD34+ cells /kg. Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of 140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients). Melphalan will be administered by central venous catheter.
Arm 2: the patients who assigned to arm 2 will receive ASCT alone as an initial treatment. The process of ASCT is as same as arm 1.
Sponsor: Nanjing University School of Medicine
Current Primary Outcome: Number of participants with hematologic complete response between BD+ASCT arm and ASCT alone arm in the treatment of AL amyloidosis [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ]
- Number of participants with organ responses between BD+ASCT arm and ASCT alone arm in the treatment of AL amyloidosis [ Time Frame: 12 months ]
- Overall survival [ Time Frame: 24 months ]
- Progression free survival [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: Nanjing University School of Medicine
Dates:
Date Received: November 15, 2013
Date Started: December 2007
Date Completion:
Last Updated: November 25, 2013
Last Verified: November 2013