A Randomized Study of 4 vs. 8 Cycles of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients
The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old.
Newly-diagnosed myeloma patient enrolled will receive 4 cycles of velcade and Dexamethasone
as front-line induction therapy. All patients finished the induction therapy will be
randomized into standard group and the study group. All patients will mobilized by
cyclophosphamide with G-CSF to collect a target of 2x106 CD34+/kg and then undergo
autologous stem cell transplantation. For standard group, patients will receive single
auto-SCT with standard conditioning of melphalan 200mg/m2. The patients in the study group
will receive single auto-SCT with conditioning of melphalan 200mg/m2 added with 4 dose of
velcade at 1.0mg/m2 during the transplantation procedure and then followed by 3 more cycles
of velcade alone as consolidation.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
60 days and 2 years after the treatment
Zhi-Xiang Shen, M.D.
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
China: Ethics Committee