Finding studies
Finding studies
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Lead
Barbara Ann Karmanos Cancer Institute
With
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of bortezomib during maintenance phase after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma. * Determine the safety and tolerability of bortezomib in these patients. Secondary * Determine the overall response rate, complete response rate, and response duration in patients treated with bortezomib at the MTD. OUTLINE: This is an open-label, dose-finding study. Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 or 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive de-escalating doses of bortezomib (at varying dosing schedules) 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. At least 6 patients are treated at the MTD. After completion of study treatment, patients are followed at 1 year. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
