Browsing by Author "Puig, Noemi"

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    Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma
    (Taylor & Francis, 2021) Hájek, Roman; Minařík, Jiří; Straub, Jan; Pour, Luděk; Jungova, Alexandra; Berdeja, Jesus G.; Boccadoro, Mario; Brozova, Lucie; Spencer, Andrew; van Rhee, Frits; Vela-Ojeda, Jorge; Thompson, Michael A.; Abonour, Rafat; Chari, Ajai; Cook, Gordon; Costello, Caitlin L.; Davies, Faith E.; Hungria, Vania T. M.; Lee, Hans C.; Leleu, Xavier; Puig, Noemi; Rifkin, Robert M.; Terpos, Evangelos; Usmani, Saad Z.; Weisel, Katja C.; Zonder, Jeffrey A.; Bařinová, Magda; Kuhn, Matyáš; Šilar, Jiří; Čápková, Lenka; Galvez, Kenny; Lu, Jin; Elliott, Jennifer; Stull, Dawn Marie; Ren, Kaili; Maisnar, Vladimír; Medicine, School of Medicine
    Aim: To evaluate the effectiveness and safety of ixazomib-lenalidomide-dexamethasone (IRd) in relapsed/refractory multiple myeloma in routine clinical practice. Patients & methods: Patient-level data from the global, observational INSIGHT MM and the Czech Registry of Monoclonal Gammopathies were integrated and analyzed. Results: At data cut-off, 263 patients from 13 countries were included. Median time from diagnosis to start of IRd was 35.8 months; median duration of follow-up was 14.8 months. Overall response rate was 73%, median progression-free survival, 21.2 months and time-to-next therapy, 33.0 months. Ixazomib/lenalidomide dose reductions were required in 17%/36% of patients; 32%/30% of patients discontinued ixazomib/lenalidomide due to adverse events. Conclusion: The effectiveness and safety of IRd in routine clinical practice are comparable to those reported in TOURMALINE-MM1.
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    Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients
    (Elsevier, 2023) Thompson, Michael A.; Boccadoro, Mario; Leleu, Xavier; Vela-Ojeda, Jorge; van Rhee, Frits; Weisel, Katja C.; Rifkin, Robert M.; Usmani, Saad Z.; Hájek, Roman; Cook, Gordon; Abonour, Rafat; Armour, Mira; Morgan, Kathryn E.; Yeh, Su-Peng; Costello, Caitlin L.; Berdeja, Jesus G.; Davies, Faith E.; Zonder, Jeffrey A.; Lee, Hans C.; Omel, Jim; Spencer, Andrew; Terpos, Evangelos; Hungria, Vania T. M.; Puig, Noemi; Fu, Chengcheng; Ferrari, Renda H.; Ren, Kaili; Stull, Dawn Marie; Chari, Ajai; Medicine, School of Medicine
    Background: Infections are a common reason for hospitalization and death in multiple myeloma (MM). Although pneumococcal vaccination (PV) and influenza vaccination (FV) are recommended for MM patients, data on vaccination status and outcomes are limited in MM. Materials and methods: We utilized data from the global, prospective, observational INSIGHT MM study to analyze FV and PV rates and associated outcomes of patients with MM enrolled 2016-2019. Results: Of the 4307 patients enrolled, 2543 and 2500 had study-entry data on FV and PV status. Overall vaccination rates were low (FV 39.6%, PV 30.2%) and varied by region. On separate multivariable analyses of overall survival (OS) by Cox model, FV in the prior 2 years and PV in the prior 5 years impacted OS (vs. no vaccination; FV: HR, 0.73; 95% CI, 0.60-0.90; P = .003; PV: HR, 0.51; 95% CI, 0.42-0.63; P < .0001) when adjusted for age, region, performance status, disease stage, cytogenetics at diagnosis, MM symptoms, disease status, time since diagnosis, and prior transplant. Proportions of deaths due to infections were lower among vaccinated versus non-vaccinated patients (FV: 9.8% vs. 15.3%, P = .142; PV: 9.9% vs. 18.0%, P = .032). Patients with FV had generally lower health resource utilization (HRU) versus patients without FV; patients with PV had higher or similar HRU versus patients without PV. Conclusion: Vaccination is important in MM and should be encouraged. Vaccination status should be recorded in prospective clinical trials as it may affect survival.
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    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 Medicine
    Multiple 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.
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    Summary of the 2019 Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling
    (Elsevier, 2020-10) Holstein, Sarah A.; Howard, Alan; Avigan, David; Bhutani, Manisha; Cohen, Adam D.; Costa, Luciano J.; Dhodapkar, Madhav V.; Gay, Francesca; Gormley, Nicole; Green, Damian J.; Hillengass, Jens; Korde, Neha; Li, Zihai; Mailankody, Sham; Neri, Paola; Parekh, Samir; Pasquini, Marcelo C.; Puig, Noemi; Roodman, G. David; Samur, Mehmet Kemal; Shah, Nina; Shah, Urvi A.; Shi, Qian; Spencer, Andrew; Suman, Vera J.; Usmani, Saad Z.; McCarthy, Philip L.; Medicine, School of Medicine
    The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Myeloma Intergroup has organized an annual workshop focused on minimal residual disease (MRD) testing and immune profiling (IP) in multiple myeloma since 2016. In 2019, the workshop took place as an American Society of Hematology (ASH) Friday Scientific Workshop entitled “Immune Profiling and Minimal Residual Disease Testing in Multiple Myeloma”. This workshop focused on four main topics: the molecular and immunological evolution of plasma cell disorders, the development of new laboratory- and imaging-based MRD assessment approaches, chimeric antigen receptor T-cell therapy research, and the statistical and regulatory issues associated with novel clinical endpoints. In this report, we provide a summary of the workshop and discuss future directions.