Clinical Trial: A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational




Official Title: A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early

Brief Summary: This protocol seeks to enroll smoldering multiple myeloma (SMM) patients with λ light chain (LC) involvement, a group of patients for whom standard of care is observation not treatment. Patients with SMM have a precursor plasma cell disorder from which light chain amyloidosis (AL) often evolves. In this trial they will have blood and bone marrow cells evaluated by molecular testing to determine their clonal λ LC variable region (VL) germline gene. The repertoire of clonal germline genes employed in AL is restricted; 70% of cases of AL involve just 7 germline donors, 5 of which are λ germline donors. The hypothesis that will be tested with this protocol is that the presence of VL germline genes associated with AL in patients with a pre-existing diagnosis of λ SMM will be indicative of risk of progression to AL.