Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) Induction Followed by HDT With ASCT and Maintenance Treatment With Velcade for Newly Diagnosed MM
1. Overview of study design
This study aims to assess the efficacy and toxicities of sequential VAD and VTD
induction followed by high dose therapy with autologous stem cell transplantation and
maintenance treatment with velcade as a first line treatment for the patients with
multiple myeloma. This study will be conducted as an open, multi-center, single arm,
prospective phase 2 study.
2. Sample size determination
The expected response rate of sequential VAD and VTD induction chemotherapy as a first
line treatment for the patients with multiple myeloma is 80%. By using Flemming’s
single stage design ( error: 0.05, error : 0.2), 55 evaluable patients are needed to
prove this hypothesis. If withdrawal rate is 10%, enrollment of total 62 patients will
be needed.
3. Duration of the Study
One year of enrollment will be needed (2006.03.1-2007.02.28). At least 24 months of
follow-up for the patients who are to be enrolled last time is needed.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate of sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) induction therapy as a first line treatment for the patients with multiple myeloma
Sung-Soo Yoon, MD PhD
Principal Investigator
Seoul National University Hospital
Singapore: Domain Specific Review Boards
KMM51
NCT00378755
March 2006
July 2008
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