*3.1.3 Daratumumab in relapsed/refractory multiple myeloma in combination therapies: the experience from the Multiple Myeloma GIMEMA Lazio Group*

Fazio et al. performed a multicentre retrospective analysis of patients with relapsed/refractory multiple myeloma treated with IMiDs or IPs-based regimens containing daratumumab in the hospitals of the GIMEMA (Gruppo Italiano Malattie Ematologiche dell'Adulto) network in the Italian region of Lazio [19]. Of 188 patients, sixty-five performed at least one cycle of therapy and were evaluable for hematologic response. The ORR was 81.97%; with four patients (6.56%) achieving a stringent complete response (sCR), 20 (32.79%) patients a complete response (CR), 5 (8.2%) patients a non-complete response (NCR), 13 (21.31%) patients a very good partial response (VGPR) and 8 (13.11%) patients a partial response (PR). After a median follow-up of 8.8 (range 0.23–22.3) months, 50 (42.37%) patients were alive maintaining response, eight (13.11%) patients presented a progression disease and one (1.64%) patients died. The overall survival and progression-free survival were 86.3% (95% CI, 79.2–94) and 70.8% (95% CI, 61.2–82), respectively. The most common grade 3 or 4 hematologic treatment-emergent adverse events (TAEs) included neutropenia, anemia and thrombocytopenia. The most common non-hematologic TAEs, of any grade, were infections, peripheral sensory neuropathy (7.6%) and fatigue (7.6%). Among the cases of infection, 17 (26%) patients presented pneumonia, eight (12%) patients FUO and five (7.7%) patients viral reactivation. Our preliminary results confirm data from POLLUX and CASTOR trial, suggesting that treatment with daratumumab in combination with lenalidomide or bortezomib plus dexamethasone is a highly effective and well-tolerated regimen to be considered for multiple myeloma patients after first relapse.
