FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Summary
RATIONALE: Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma.
Description
OBJECTIVES:
- Determine the safety and efficacy of FR901228 (depsipeptide) in patients with relapsed or refractory multiple myeloma.
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.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Multiple Myeloma and Plasma Cell Neoplasm
Intervention
romidepsin
Location
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx
New York
United States
10461
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00066638
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:55:00-0400
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Medical and Biotech [MESH] Definitions
Smoldering Multiple Myeloma
An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.
Leukemia, Plasma Cell
A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Myeloma Proteins
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
Immunoglobulin Light-chain Amyloidosis
A nonproliferative disorder of the PLASMA CELL characterized by excessive production and misfolding of IMMUNOGLOBULIN LIGHT CHAINS that form insoluble amyloid fibrils (see AMYLOID DEPOSITS) in various tissues. Clinical features include LIVER FAILURE; MULTIPLE MYELOMA; NEPHROTIC SYNDROME; RESTRICTIVE CARDIOMYOPATHY, and neuropathies.
Bortezomib
A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.
