CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Completed · Phase 2
Conditions studied: Multiple Myeloma
In brief
RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis. PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.
Key facts
- Study ID
- NCT00091260
- Run by
- Vaishali Sanchorawala
- People needed
- 82
- Starts
- 2004-01-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2017-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary systemic (AL) amyloidosis
- Tissue amyloid deposits or positive fat aspirate
- Meets 1 of the following criteria for AL type disease:
- Serum or urine monoclonal protein by immunofixation electrophoresis
- Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- SWOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- White blood count> 3,000/mm\^3
- Hemoglobin > 8 g/dL
- Platelet count > 100,000/mm\^3
- Absolute neutrophil count > 1,000/mm\^3
- Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior thalidomide for AL amyloidosis allowed
- Chemotherapy
You may not qualify if…
- No secondary or familial amyloidosis
- No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions
- No prior CC-5013
- Renal
- No dialysis
- Cardiovascular
- No symptomatic cardiac arrhythmia
- No oxygen-dependent restrictive cardiomyopathy
- Other
- No untreated or uncontrolled infection
- No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast
- No other serious medical illness that would preclude study participation
- No history of hypersensitivity reaction to thalidomide
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Where it is running
- Cancer Research Center at Boston Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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