Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma
- Determine response rate, as defined by resolution of bone marrow plasmacytosis and
monoclonal paraproteinemia, in the first year after autologous peripheral blood stem
cell transplantation in patients with intermediate or advanced multiple myeloma treated
with adjuvant bortezomib.
- Compare progression-free survival of patients treated with adjuvant bortezomib with
historical controls treated with autologous transplantation alone.
- Determine the toxicity of this drug in these patients (phase I).
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free and overall survival
Gary J. Schiller, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|