agent daratumumab (iii) outside clinical trials. The response categories were defined according to the International Myeloma Working Group consensus criteria. OS and PFS were estimated using the Kaplan-Meier method. Safety was evaluated through the rate of infusion related reactions (IRR) and adverse events (AE). Results: 41 consecutive pts were analyzed. The median age was 68 years, including 7 pts (17%) older than 75 years. Eight pts (20%) had ECOG performans status >2. Ten (24%) had high-risk cytogenetic, and 13 (32%) had extra-medullary disease. The median number of prior therapies was 4 (range 2-9). All pts were previously exposed to PI and IMID, 59% were refractory to both PI and IMID and 95% refractory to IMID. All pts were refractory to the last line of therapy. The ORR was 24.4% (10/41), including 4.9% VGPR (2/41). At a median follow-up time of 6.5 months, all pts had discontinued daratumumab because of disease progression. The median PFS was 1.9 months (CI 1.4-2.5). For pts achieving partial response or better, the median PFS was 10.1 months ). Median time to response for those patients was 1.2 months (CI 1.0-1.8), and median response duration was 9.0 months
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