Chari, AjaiRodríguez Otero, PaulaMcCarthy, HelenSuzuki, KenshiHungria, VaniaSureda, AnnaPerrot, AuroreHulin, CyrilleMagen, HilaIida, ShinsukeMaisnar, VladimirKarlin, LionelPour, LudekParasrampuria, Dolly A.Masterson, TaraKosh, MicheleYang, ShiyiDelioukina, MariaQi, MingCarson, RobinTouzeau, Cyrille2021-02-182021-02-182020-07-30https://hdl.handle.net/2445/174026Daratumumab is a CD38-targeting monoclonal antibody approved for intravenous (IV) infusion for multiple myeloma (MM). We describe the Phase II PLEIADES study of a subcutaneous formulation of daratumumab (DARA SC) in combination with standard-of-care regimens: DARA SC plus bortezomib/lenalidomide/dexamethasone (D-VRd) for transplant-eligible newly diagnosed MM (NDMM); DARA SC plus bortezomib/melphalan/prednisone (D-VMP) for transplant-ineligible NDMM; and DARA SC plus lenalidomide/dexamethasone (D-Rd) for relapsed/refractory MM. In total, 199 patients were treated (D-VRd, n = 67; D-VMP, n = 67; D-Rd, n = 65). The primary endpoints were met for all cohorts: the ≥very good partial response (VGPR) rate after four 21-day induction cycles for D-VRd was 71·6% [90% confidence interval (CI) 61·2-80·6%], and the overall response rates (ORRs) for D-VMP and D-Rd were 88·1% (90% CI 79·5-93·9%) and 90·8% (90% CI 82·6-95·9%). With longer median follow-up for D-VMP and D-Rd (14·3 and 14·7 months respectively), responses deepened (ORR: 89·6%, 93·8%; ≥VGPR: 77·6%, 78·5%), and minimal residual disease-negativity (10-5 ) rates were 16·4% and 15·4%. Infusion-related reactions across all cohorts were infrequent (≤9·0%) and mild. The median DARA SC administration time was 5 min. DARA SC with standard-of-care regimens demonstrated comparable clinical activity to DARA IV-containing regimens, with low infusion-related reaction rates and reduced administration time.10 p.application/pdfengcc by (c) Chari et al., 2020http://creativecommons.org/licenses/by-nc/3.0/es/Anticossos monoclonalsMieloma múltipleMonoclonal antibodiesMultiple myelomainfo:eu-repo/semantics/article2021-02-15info:eu-repo/semantics/openAccess33216361