Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
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.