Real-world sustained minimal residual disease (MRD) negativity using NGS in multiple myeloma.

Abstract

e19280 Background: MRD assessment has been increasingly incorporated into guidelines and routine care for patients (pts) with multiple myeloma (MM). It has been widely shown that pts who achieve deep MRD negativity (MRD-) have longer PFS/OS. Clinical guidelines now include sustained MRD- (two consecutive MRD- results; (10−5, 12 mo. apart) as a response criterion. . NGS MRD (clonoSEQ; Adaptive Biotechnologies; Seattle, WA) is the only FDA authorized method for bone-marrow MRD assessment in MM. A large longitudinal database of quantitative NGS MRD values from routine patient care now enables real-world analysis. We used our data to provide insight into testing patterns and sustained MRD-. Methods: The population included internal data of NGS MRD clinical samples from Jan 2018 to Jan 2020. We examined MRD- achievement overall and sustained MRD- as defined by guidelines. For pts who achieved sustained MRD- and had subsequent MRD testing, we examined if they remained in an MRD- state. Results: We identified 1,675 pts with MM who had ≥1 MRD tests after baseline Clonality (ID) assessment. The age/sex distribution (med. age = 65; 58% male) was consistent with epidemiologic data. 837 (49.9%) and 541 (32.2%) achieved MRD- at 10−5 or 10−6 thresholds, respectively. Of the 190 pts with ≥2 MRD tests at least 12 mos. apart, 82 (43.2%) and 45 (23.7%) had sustained MRD- at 10−5 and 10−6 thresholds, respectively. Of 82 pts who achieved 12 mo. sustained MRD- at 10−5, 15 had a subsequent MRD test, of which all remained MRD-. Of 45 pts who achieved 12 mo. sustained negativity at 10−6, 4 had a subsequent MRD test, of which all remained MRD-. Conclusions: We believe this represents one of the earliest real-world study examining NGS MRD attainment of sustained MRD- defined by guidelines. It is notable that many pts reached deep MRD negativity, with a significant percentage having sustained MRD negativity meet guideline-defined criteria. Long-term follow-up and incorporation of clinical parameters & outcomes data will enable further insights from this real-world dataset. [Table: see text]