Clinical Trial: Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment (Which May Include High Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT)) in Patients With In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) (as described below), can be used as a predictive method of response to treatment in amyloidosis.
Minimal residual disease (MRD) is a concept that has gained significant value as a prognostic predictor and has become an emerging constituent of complete response (CR) reassessment in multiple myeloma (MM) patients. Studies in MM have demonstrated that up to 30% of patients achieving a CR after high-dose therapy will still have detectable MRD in the bone marrow as measured by standard-sensitivity flow cytometry or by molecular assays. Virtually every study examining MRD in MM has reported that among patients achieving a CR, those who were MRD negative (MRD-) had a significantly superior progression-free survival, with some studies reporting superior overall survival.
As amyloidosis is a disease that is very similar to multiple myeloma, the investigators wish to evaluate the concept in this disease.
Sponsor: Shayna Sarosiek
Current Primary Outcome: Number of samples that have a successful isolation of a plasma cell clone [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of cases in which minimal residual disease observed in specimens correlates with response to treatment [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Boston Medical Center
Dates:
Date Received: March 14, 2016
Date Started: May 2016
Date Completion: December 2019
Last Updated: January 10, 2017
Last Verified: January 2017
