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Item Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US(Springer, 2021) Davies, Faith; Rifkin, Robert; Costello, Caitlin; Morgan, Gareth; Usmani, Saad; Abonour, Rafat; Palumbo, Antonio; Romanus, Dorothy; Hajek, Roman; Terpos, Evangelos; Cherepanov, Dasha; Stull, Dawn Marie; Huang, Hui; Leleu, Xavier; Berdeja, Jesus; Lee, Hans C.; Weisel, Katja; Thompson, Michael; Boccadoro, Mario; Zonder, Jeffrey; Cook, Gordon; Puig, Noemi; Vela-Ojeda, Jorge; Farrelly, Eileen; Raju, Aditya; Blazer, Marlo; Chari, Ajai; Medicine, School of MedicineMultiple available combinations of proteasome inhibitors, immunomodulators (IMIDs), and monoclonal antibodies are shifting the relapsed/refractory multiple myeloma (RRMM) treatment landscape. Lack of head-to-head trials of triplet regimens highlights the need for real-world (RW) evidence. We conducted an RW comparative effectiveness analysis of bortezomib (V), carfilzomib (K), ixazomib (I), and daratumumab (D) combined with either lenalidomide or pomalidomide plus dexamethasone (Rd or Pd) in RRMM. A retrospective cohort of patients initiating triplet regimens in line of therapy (LOT) ≥ 2 on/after 1/1/2014 was followed between 1/2007 and 3/2018 in Optum's deidentified US electronic health records database. Time to next treatment (TTNT) was estimated using Kaplan-Meier methods; regimens were compared using covariate-adjusted Cox proportional hazard models. Seven hundred forty-one patients (820 patient LOTs) with an Rd backbone (VRd, n = 349; KRd, n = 218; DRd, n = 99; IRd, n = 154) and 348 patients (392 patient LOTs) with a Pd backbone (VPd, n = 52; KPd, n = 146; DPd, n = 149; IPd, n = 45) in LOTs ≥2 were identified. More patients ≥75 years received IRd (39.6%), IPd (37.8%), and VRd (36.7%) than other triplets. More patients receiving VRd/VPd were in LOT2 vs other triplets. Unadjusted median TTNT in LOT ≥ 2: VRd, 13.9; KRd, 8.7; IRd, 11.4; DRd, not estimable (NE); and VPd, 12.0; KPd, 6.7; IPd, 9.5 months; DPd, NE. In covariate-adjusted analysis, only KRd vs DRd was associated with a significantly higher risk of next LOT initiation/death (HR 1.72; P = 0.0142); no Pd triplet was significantly different vs DPd in LOT ≥ 2. Our data highlight important efficacy/effectiveness gaps between results observed in phase 3 clinical trials and those realized in the RW.Item Role of daratumumab in relapsed or refractory multiple myeloma patient: A meta-analysis and literature to review(Wolters Kluwer, 2022) Tauseef, Abubakar; Zafar, Maryam; Silberstein, Peter; Nahas, Joseph; Frederickson, Thomas; Abodunrin, Faith; Abbas, Anum; Arshad, Wafa; Lateef, Noman; Rangoonwala, Hussain; Albagoush, Sara; Mirza, Mohsin; Medicine, School of MedicineIntroduction: With an increase in number of cases of relapsed or refractory multiple myeloma (RRMM), scientist have discovered various combination of medications among which one is daratumumab, Daratumumab is a mono-clonal antibody which attacks CD-38 markers present in abundance on the surface of myeloma cells and is used universally for the treatment of primary newly diagnosed multiple myeloma patients. Methods and methodology: This meta-analysis was conducted according to Cochrane Collaboration guidelines in which initially 679 articles were evaluated for relevance on abstract level followed by full text screening of final list of 45 articles. Out of the 45 articles, only 10 articles qualified for selection criteria for eligibility. Three Phase 3 randomized control clinical trials which includes primary outcomes of progression free span and secondary outcomes including complete response, partial response or very good partial response and adverse effects reported were included in this study. Results: A total of three studies including 1533 patients (849 in Daratumumab treatment group while 684 patients in control group) were included in the study. All three of these studies were phase 3 clinical trial conducted to observe the role of daratumumab in relapsed and refractory multiple myeloma. Mean age reported was 65 years in both treatment and control groups. This study showed that daratumumab improves primary and secondary outcomes including progression free span, overall response rate, very good partial response, and complete response. However, daratumumab increases drug induced adverse effects. Conclusion: Our study confirmed that daratumumab in combination therapy improved primary and secondary outcomes when compared with platinum-based chemotherapy, but more adverse effects were reported in the combination group. So, we recommend that combination therapy should include daratumumab in treatment of relapsed and refractory multiple myeloma patients.