Spots Global Cancer Trial Database for FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma

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Trial Identification

Brief Title: FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma

Official Title: A Phase 2 Study of Depsipeptide in Relapsed/Refractory Multiple Myeloma

Study ID: NCT00066638

Conditions

DS Stage II Plasma Cell Myeloma

DS Stage III Plasma Cell Myeloma

Refractory Plasma Cell Myeloma

Interventions

Romidepsin

Laboratory Biomarker Analysis

Study Description

Brief Summary: 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

Detailed Description: 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.