Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
This is an open label clinical trial to evaluate the efficacy of single autologous
hematopoietic stem cell transplantation in newly diagnosed multiple myeloma patients. All
patients will receive 4-6 cycles of induction therapy which includes VAD chemotherapy
(vincristin, adriamycin and dexamethasone) or thalidomide/dexamethasone. After peripheral
hematopoietic stem cell mobilization and apheresis, patients will receive a standard
conditioning with melphalan 200mg/m2 followed by thalidomide maintenance therapy at
100-200mg orally daily starting from D+60 till disease progression or untolerable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate: CR/nCR/VGPR
6 months after auto-PBSCT
Jiong HU, M.D.
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
China: Ethics Committee