Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- response rate: CR/nCR/VGPR
- Status
- Suspended
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jiong HU
Head, Blood and Marrow Transplantation Center, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate
- •Measurable serum and/or urinary paraprotein
- •European Cooperative Oncology Group performance status 0-3
- •Serum bilirubin \< 1.5x the upper limit of normal (ULN)
- •Serum alanine transaminase (ALT)/aspartate transaminase values \< 2.5 x ULN
- •Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study
- •Exclusion criteria:
- •Woman of child bearing potential
- •Non-secretory MM
- •Serum creatinine \> 400 Micromol/l after initial resuscitation
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
response rate: CR/nCR/VGPR
Time Frame: 6 months after auto-PBSCT
Secondary Outcomes
- toxicity(3 years)
- progression free survival(3 years)
- overall survival(3 years)