Expired Study
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Boston, Massachusetts 02118


Purpose:

RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis. PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.


Study summary:

OBJECTIVES: Primary - To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis. - To determine the hematologic response rate in patients treated with this regimen. Secondary - To assess organ response in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.


Criteria:

Inclusion Criteria: DISEASE CHARACTERISTICS: - Diagnosis of primary systemic amyloidosis PATIENT CHARACTERISTICS: - Not pregnant - Negative pregnancy test - Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin) PRIOR CONCURRENT THERAPY: - Recovered from prior therapy - Permanent or stable side effects/changes allowed - Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed - More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy Exclusion Criteria: - No secondary or familial amyloidosis - No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions) - No prior cumulative doses of oral melphalan > 200 mg - No more than one prior course of high-dose melphalan with stem cell transplant


NCT ID:

NCT00679367


Primary Contact:

Principal Investigator
David C. Seldin, MD, PhD
Boston Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02118
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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