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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00679367
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00679367
Study Brief:
Protocol Section:
NCT00679367