The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or thalidomide/dexamethasone between 18 to 65 years.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Single ASCT with Thalidomide maintenance: 1. Single Autologous Stem Cell Transplantation: conditioning with Melphalan 200mg/m2 (iv) 2. Thalidomide maintenance: starting from D60 after transplantation at 100-200mg daily (Oral)
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China
response rate: CR/nCR/VGPR
Time frame: 6 months after auto-PBSCT
overall survival
Time frame: 3 years
progression free survival
Time frame: 3 years
toxicity
Time frame: 3 years
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