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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT02245867
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a confirmed diagnosis of AL amyloidosis based on accepted clinical and laboratory criteria.
* Patients are greater than 21 years old.
* Female patients are not of child bearing potential or if they are of child bearing potential, they must not be pregnant or breast-feeding.
* Patients have a life expectancy greater than 3 months.
* Patients have an Eastern Cooperative Oncology Group (ECOG)-specified performance status of less than or equal to 3.
* Patients to be included are those with measurable, localized amyloid deposits (larynx, subcutaneous tissue, muscle, lung, lymph nodes) or clinically evident systemic disease (liver, kidney, heart, etc).
* Only patients with prior systemic therapy with relapsed/refractory disease are eligible, unless they have declined or are not eligible for high-dose melphalan and autologous hematopoietic stem cell transplant (HSCT) or any other standard therapy that has been known to be life-prolonging or life-saving.
* Patients have adequate organ function.
* Patients with cancer are eligible provided they meet specific criteria.
* Patients must provide signed, written, informed consent and be willing and able to comply with eligibility requirements, scheduled, visits, and follow-up studies.
Exclusion Criteria:
* Non-AL amyloidosis.
* Renal failure (on dialysis).
* Females who are pregnant or breast-feeding.
* ECOG Performance Status greater than 3.
* Seriously limited cardiac, renal, or hepatic function.
* Uncontrolled infection or significant co-morbidity (e.g., uncontrolled diabetes, severe diarrhea).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02245867
Study Brief:
Protocol Section:
NCT02245867