MINARIK, Jiri, Ludek POUR, Vladimir MAISNAR, Ivan SPICKA, Alexandra JUNGOVA, Tomas JELINEK, Lucie BROŽOVÁ, Petra KRHOVSKA, Vlastimil SCUDLA and Roman HAJEK. Single agent daratumumab in advanced multiple myeloma possesses significant efficacy even in an unselected "real-world" population. Biomedical Papers, Olomouc: Palacky University. Olomouc: Palacky University, 2019, vol. 163, No 3, p. 279-283. ISSN 1213-8118. Available from: https://dx.doi.org/10.5507/bp.2018.064.
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Basic information
Original name Single agent daratumumab in advanced multiple myeloma possesses significant efficacy even in an unselected "real-world" population
Authors MINARIK, Jiri (203 Czech Republic, guarantor), Ludek POUR (203 Czech Republic), Vladimir MAISNAR (203 Czech Republic), Ivan SPICKA (203 Czech Republic), Alexandra JUNGOVA (203 Czech Republic), Tomas JELINEK (203 Czech Republic), Lucie BROŽOVÁ (203 Czech Republic, belonging to the institution), Petra KRHOVSKA (203 Czech Republic), Vlastimil SCUDLA (203 Czech Republic) and Roman HAJEK (203 Czech Republic).
Edition Biomedical Papers, Olomouc: Palacky University, Olomouc, Palacky University, 2019, 1213-8118.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30204 Oncology
Country of publisher Czech Republic
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 1.000
RIV identification code RIV/00216224:14110/19:00108570
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.5507/bp.2018.064
UT WoS 000489991000015
Keywords in English multiple myeloma; relapsed and refractory; daratumumab; progression free survival; overall survival
Tags 14119612, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 16/1/2020 13:23.
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.
Links
NV17-29343A, research and development projectName: Analýza mikroprostředí kostní dřeně u extramedulárního relapsu mnohočetného myelomu
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