Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Oncotherapeutics
OBJECTIVES: Primary * Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid. * Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. Secondary * Determine the time to response and overall survival of patients treated with this regimen. * Determine the effects of this regimen on renal failure associated with MM in these patients. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
