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 P
Brief 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.
Detailed Summary:
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
