Status:
COMPLETED
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Lead Sponsor:
Boston Medical Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 div...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00679367
Start Date
May 1 2008
End Date
May 1 2015
Last Update
February 20 2017
Active Locations (1)
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1
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118