1. Daratumumab plus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: frailty subgroup analysis of MAIA
- Author
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Thierry Facon, Gordon Cook, Saad Z. Usmani, Cyrille Hulin, Shaji Kumar, Torben Plesner, Cyrille Touzeau, Nizar J. Bahlis, Supratik Basu, Hareth Nahi, Hartmut Goldschmidt, Hang Quach, Mohamad Mohty, Christopher P. Venner, Katja Weisel, Noopur Raje, Benjamin Hebraud, Karim Belhadj-Merzoug, Lotfi Benboubker, Olivier Decaux, Salomon Manier, Denis Caillot, Jon Ukropec, Huiling Pei, Rian Van Rampelbergh, Clarissa M. Uhlar, Rachel Kobos, Sonja Zweegman, CHU Lille, Leeds Institute of Cancer and Pathology [U.K.], The Levine Cancer Institute, Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Mayo Clinic [Rochester], University of Southern Denmark (SDU), Centre hospitalier universitaire de Nantes (CHU Nantes), University of Calgary, University of Wolverhampton, Karolinska University Hospital [Stockholm], Karolinska Institute, UniversitätsKlinikum Heidelberg, University of Melbourne, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University of Alberta, Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), Massachusetts General Hospital [Boston], Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Henri Mondor [Créteil], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Janssen Research & Development, Amsterdam UMC - Amsterdam University Medical Center, This study was sponsored by Janssen Research & Development, LLC. The authors thank the patients who participated in this study and their families, as well as the study co-investigators, research nurses, and coordinators at each of the clinical sites. Medical writing and editorial support were provided by Grace Wang, PharmD, of Cello Health Communications/MedErgy, and were funded by Janssen Global Services, LLC., Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Henri Mondor, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Amsterdam UMC, Hematology, CCA - Cancer Treatment and quality of life, Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Jonchère, Laurent
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Cancer Research ,health care facilities, manpower, and services ,[SDV]Life Sciences [q-bio] ,Dexamethasone ,03 medical and health sciences ,0302 clinical medicine ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Multiple Myeloma/diagnosis ,Lenalidomide ,Retrospective Studies ,Frailty ,Antineoplastic Combined Chemotherapy Protocols/adverse effects ,Antibodies, Monoclonal ,Hematology ,Dexamethasone/therapeutic use ,3. Good health ,[SDV] Life Sciences [q-bio] ,Frailty/diagnosis ,Lenalidomide/therapeutic use ,Oncology ,030220 oncology & carcinogenesis ,Multiple Myeloma ,human activities ,030215 immunology - Abstract
In the phase 3 MAIA study of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM), daratumumab plus lenalidomide/dexamethasone (D-Rd) improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd). We present a subgroup analysis of MAIA by frailty status. Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit, intermediate, non-frail (fit + intermediate), or frail. Of the randomized patients (D-Rd, n = 368; Rd, n = 369), 396 patients were non-frail (D-Rd, 196 [53.3%]; Rd, 200 [54.2%]) and 341 patients were frail (172 [46.7%]; 169 [45.8%]). After a 36.4-month median follow-up, non-frail patients had longer PFS than frail patients, but the PFS benefit of D-Rd versus Rd was maintained across subgroups: non-frail (median, not reached [NR] vs 41.7 months; hazard ratio [HR], 0.48; P P = 0.003). Improved rates of complete response or better and minimal residual disease (10–5) negativity were observed for D-Rd across subgroups. The most common grade 3/4 treatment-emergent adverse event in non-frail and frail patients was neutropenia (non-frail, 45.4% [D-Rd] and 37.2% [Rd]; frail, 57.7% and 33.1%). These findings support the clinical benefit of D-Rd in transplant-ineligible NDMM patients enrolled in MAIA, regardless of frailty status.
- Published
- 2022
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