Role Of Clonoseq (R), A Next-Generation Sequencing (Ngs) Assay And Pet/Ct As A Measure Of Minimal Residual Disease Negativity Among Patients With Multiple Myeloma

Background: The clonoSEQ® Assay (Adaptive Biotechnologies; Seattle, WA) is an in vitro diagnostic that uses next-generation sequencing (NGS) to identify and quantify rearranged IgH (VDJ), IgH (DJ), IgK, and IgL receptor gene sequences, as well as translocated BCL1/IgH (J) and BCL2/IgH (J) sequences in extracted DNA. clonoSEQ assay includes primers that amplify specific genomic regions present as diploid copies in normal genomic DNA (gDNA) to allow determination of total nucleated cell content. In the assessment of clonoSEQ Clonality (ID), the immune repertoire of the sample is checked for the presence of DNA sequences specific to “dominant” clone(s). For clonoSEQ Tracking MRD assessment, the complete immunoglobulin receptor repertoire is again assessed, and the previously identified dominant clonotype sequence(s) are detected and quantified to determine the sample MRD level. The MRD is expressed as a frequency that quantifies the level of residual disease based on the number of remaining copies of the initially dominant sequence(s) relative to the total number of nucleated cells in the sample. We have evaluated the rates of MRD negativity among myeloma patients achieving hematological response and its impact on the progression free survival.