CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis (NCT00091260) | Clinical Trial Compass
CompletedPhase 2
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
United States82 participantsStarted 2004-01
Plain-language 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 dexamethasone in treating patients with primary systemic amyloidosis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
* 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 uncon…
What they're measuring
1
Number of Patients Removed From Study Treatment Due to Toxicities
Timeframe: 1 year
2
Number of Patients With Hematologic Response With Single-agent CC-5013