Refractory Plasma Cell Myeloma Clinical Trial
Official title:
A Phase 2 Study of Depsipeptide in Relapsed/Refractory Multiple Myeloma
Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma
PRIMARY OBJECTIVES:
I. To evaluate the safety and efficacy of depsipeptide in patients with refractory or
relapsed multiple myeloma (MM).
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients who achieve a stable plateau (stable paraprotein levels or urine protein excretion
over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy
comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 5-12.5
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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