Status:
COMPLETED
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Lead Sponsor:
Vaishali Sanchorawala
Collaborating Sponsors:
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis. * Determine the objective hematologic response rate in patients treated with this drug...
Eligibility Criteria
Inclusion
- 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
- More than 4 weeks since prior cytotoxic chemotherapy
- Endocrine therapy
- Prior steroids for AL amyloidosis allowed
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- Surgery
- Prior surgery allowed
- Other
- Recovered from all prior therapy
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00091260
Start Date
January 1 2004
End Date
May 1 2015
Last Update
February 20 2017
Active Locations (1)
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1
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118