Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00091260
Eligibility Criteria:
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00091260
Study Brief:
Protocol Section:
NCT00091260