Assessments
Cancer
ADVERSE EVENT, T(4;14), EVENTS, DISEASE, T(14;16), CANCER
Disease assessments were performed by investigators every cycle based on local laboratory for serum, urine M-protein, and free light chain (FLC) parameters using IMWG criteria [For patients with suspected isatuximab interference on serum immunofixation (IFE), the Sebia HYDRASHIFT 2/4 Isatuximab IFE test was used by the central laboratory to specifically measure endogenous M-protein. The adjusted response defined the final CR rate per IMWG criteria.High-risk cytogenetic status was determined based on the presence of del17p, t(4;14), t(14;16), and 1q21+ by both local and central fluorescence in situ hybridization assessments.MRD was assessed by NGF and NGS at 10Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.