Jiri Minarik1, Ludek Pour2, Vladimir Maisnar3, Ivan Spicka4, Alexandra Jungova5, Tomas Jelinek6, Lucie Brozova7, Petra Krhovska1, Vlastimil Scudla1, Roman Hajek6. 1. Department of Hemato-oncology, University Hospital Olomouc and Faculty of Medicine, Palacky University Olomouc, Czech Republic. 2. Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Czech Republic. 3. Department of Clinical Hematology, University Hospital Hradec Kralove, Czech Republic. 4. Department of Internal Medicine, University Hospital Praha, Czech Republic. 5. Department of Haemato-Oncology, University Hospital Pilzen, Czech Republic. 6. Department of Haematooncology, University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Czech Republic. 7. Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University Brno, Czech Republic.
Abstract
OBJECTIVE: The treatment of relapsed and refractory multiple myeloma (RRMM) remains challenging. The outcomes in highly pretreated populations are unsatisfactory and there is urgent need for novel and safe therapeutic approaches. Recently, daratumumab has been approved for RRMM with promising results even in monotherapy. The aim of this study was to assess the efficacy of single agent daratumumab outside a clinical trial. PATIENTS AND METHODS: 14 patients with RRMM and significant pretreatment (median 4.5 previous lines) entered a specific healthcare program and received treatment with single agent daratumumab. They were followed for therapeutic response based on IMWG criteria, and incidence of adverse events. The data were collected using the Registry of Monoclonal Gammopathies. RESULTS: The overall response rate was 38.5%. 23.1% of patients reached very good partial response, 15.4% reached partial remission, 15.4% had minimal response, 38.5% had stable disease and 7.7% had progressive disease. The median progression free survival was 4.6 months and median overall survival was not achieved. The toxicities were mostly mild, only infectious complications and hematological toxicity reached grade III. CONCLUSION: We conclude that daratumumab has significant activity in highly pretreated RRMM even as a single agent, with an acceptable toxicity profile and survival impact.
OBJECTIVE: The treatment of relapsed and refractory multiple myeloma (RRMM) remains challenging. The outcomes in highly pretreated populations are unsatisfactory and there is urgent need for novel and safe therapeutic approaches. Recently, daratumumab has been approved for RRMM with promising results even in monotherapy. The aim of this study was to assess the efficacy of single agent daratumumab outside a clinical trial. PATIENTS AND METHODS: 14 patients with RRMM and significant pretreatment (median 4.5 previous lines) entered a specific healthcare program and received treatment with single agent daratumumab. They were followed for therapeutic response based on IMWG criteria, and incidence of adverse events. The data were collected using the Registry of Monoclonal Gammopathies. RESULTS: The overall response rate was 38.5%. 23.1% of patients reached very good partial response, 15.4% reached partial remission, 15.4% had minimal response, 38.5% had stable disease and 7.7% had progressive disease. The median progression free survival was 4.6 months and median overall survival was not achieved. The toxicities were mostly mild, only infectious complications and hematological toxicity reached grade III. CONCLUSION: We conclude that daratumumab has significant activity in highly pretreated RRMM even as a single agent, with an acceptable toxicity profile and survival impact.
Authors: Szilvia Lovas; Gergely Varga; Péter Farkas; Tamás Masszi; Nikolett Wohner; Ágnes Bereczki; Nóra Adamkovich; Zita Borbényi; Árpád Szomor; Hussain Alizadeh; Erika Szaleczky; Krisztina Wolf; Tamás Schneider; Márk Plander; Tamás Szendrei; Ottó Csacsovszki; Zoltán Csukly; Péter Rajnics; Miklós Egyed; Zsolt Nagy; László Rejtő; Árpád Illés; Gábor Mikala; László Váróczy Journal: Int J Hematol Date: 2019-08-07 Impact factor: 2.490
Authors: Benjamin Motais; Sandra Charvátová; Zuzana Walek; Matouš Hrdinka; Ryszard Smolarczyk; Tomasz Cichoń; Justyna Czapla; Sebastian Giebel; Michal Šimíček; Tomáš Jelínek; Tereza Ševčíková; Jiří Sobotka; Zdeněk Kořístek; Roman Hájek; Juli R Bagó Journal: Cells Date: 2021-04-21 Impact factor: 6.600