CompletedNot Applicable

Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis

United States45 participantsStarted 2016-11-21

Plain-language summary

In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) can be used as a predictive method of response to treatment in amyloidosis.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Isolation of a plasma cell clone

Timeframe: 1 year

Trial details

NCT IDNCT02716103

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-09-04

View on ClinicalTrials.gov More Amyloidosis trials