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:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT02716103
Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proven systemic AL amyloidosis defined as
* At least one + Congo Red stain
* Proof of a clonal plasma cell dyscrasia by:
* Immunofixation electrophoresis (IFE) of the urine or serum
* Light chain restriction based on Immunohistochemistry (IHC) in bone marrow plasma cells or in the amyloid tissue
* Must be scheduled to undergo antineoplastic therapy (this may include high dose melphalan and Autologous Stem Cell Transplantation) for AL Amyloidosis (Part II enrollments only)
Exclusion Criteria:
* Co-existing Multiple Myeloma
* Prior antineoplastic treatment for AL amyloidosis at time of enrollment.
* Prior negative bone marrow biopsy showing no identifiable clone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02716103
Study Brief:
Protocol Section:
NCT02716103