Validation of multiple myeloma minimal residual disease assay using flow cytometry

Abstract

Flow Cytometry has become standard in the management of patients with Multiple Myeloma (MM). It plays a significant role during the diagnosis because it’s a fast and conclusive readout of Plasma Cell (PCs) clonality. Recent advances in MM's treatment result in significantly better outcomes, defined as increased progression-free survival (PFS) and overall survival (OS). Since there is a proven correlation between the extent of response and prolonged survival, there is an urgent need for highly sensitive assays to detect minimal residual disease (MRD). Next-generation flow cytometry has become a valuable approach for sensitive evaluation of complete response (CR). Although many laboratories perform flow cytometry MRD testing, there are significant differences in antibody panels, gating strategies, and minimal event counts. Therefore, Cytometry societies such as the International Clinical Cytometry Society and the European Society for Clinical Cell Analysis recognize a strong need to establish minimally acceptable requirements and recommendations to perform such complex testing. This thesis aims to validate a highly sensitive, fully standardized MRD assay that can serve as a monitoring test for MM patients seen at Upstate University Hospital.