https://m2.mtmt.hu/ eng 2026-09-21 05:14 JournalArticle 30476882 VALIDATED true 0 false 2026-07-17T07:55:11.404+0000 2025-10-03T08:56:41.714+0000 2019-02-27T08:30:22.764+0000 true 10063602 Frankó Orsolya /api/admin/10063602 Admin true 10063602 2025-10-03T11:05:55.362+0000 2025-10-03T11:05:55.362+0000 2023-04-24T09:58:01.486+0000 true 10023268 Házkötő Béláné /api/admin/10023268 Admin true 10023268 Admin 10065569 /api/admin/10065569 Pécsi Éva true true 2023-06-05T15:04:38.794+0000 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Mateos, María-Victoria Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma true true /api/journal/1394667 REVIEWED true false 1394667 false 1394667 true 0028-4793 1533-4406 Journal FOREIGN 378 6 518 528 518 11 2018 The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma.In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival.At a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P<0.001). The overall response rate was 90.9% in the daratumumab group, as compared with 73.9% in the control group (P<0.001), and the rate of complete response or better (including stringent complete response) was 42.6%, versus 24.4% (P<0.001). In the daratumumab group, 22.3% of the patients were negative for minimal residual disease (at a threshold of 1 tumor cell per 105 white cells), as compared with 6.2% of those in the control group (P<0.001). The most common adverse events of grade 3 or 4 were hematologic: neutropenia (in 39.9% of the patients in the daratumumab group and in 38.7% of those in the control group), thrombocytopenia (in 34.4% and 37.6%, respectively), and anemia (in 15.9% and 19.8%, respectively). The rate of grade 3 or 4 infections was 23.1% in the daratumumab group and 14.7% in the control group; the rate of treatment discontinuation due to infections was 0.9% and 1.4%, respectively. Daratumumab-associated infusion-related reactions occurred in 27.7% of the patients.Among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than the same regimen without daratumumab. The daratumumab-containing regimen was associated with more grade 3 or 4 infections. (Funded by Janssen Research and Development; ALCYONE ClinicalTrials.gov number, NCT02195479 .). true true 2019 true true true false true false NONE 2026-07-17 false 881 0 879 687 9 878 862 815 799 863 863 671 671 689 192 0 881 689 879 687 0 1 1 Folyóiratcikk Journal Article 24 862 Könyvrészlet Chapter in Book 25 14 Könyv Book 23 1 Egyéb konferenciaközlemény Conference paper 31 1 Egyéb konferenciakötet Conference proceedings 32 0 Oltalmi formák Protection forms 26 1 Disszertáció Thesis 28 0 Egyéb Miscellaneous 29 2 Alkotás Achievement 22 0 Kutatási adat Research data 33 0 Folyóiratcikk Journal Article 24 0 0 0 Könyvrészlet Chapter in Book 25 0 0 0 Könyv Book 23 0 0 0 Egyéb konferenciaközlemény Conference paper 31 0 0 0 Egyéb konferenciakötet Conference proceedings 32 0 0 0 Oltalmi formák Protection forms 26 0 0 0 Disszertáció Thesis 28 0 0 0 Egyéb Miscellaneous 29 0 0 0 Alkotás Achievement 22 0 0 0 Kutatási adat Research data 33 0 0 0 2018 0 69 56 69 56 2019 0 116 93 116 93 2020 0 203 152 203 152 2021 0 179 150 179 150 2022 0 93 75 93 75 2023 0 62 48 62 48 2024 0 63 42 63 42 2025 0 70 51 70 51 2026 0 26 22 26 22 D1 false false false false 2019-05-22T12:40:19.137+0000 2019-02-27T08:34:30.798+0000 I. Sz. Belgyógyászati Klinika (SE / AOK / K); III. Sz. 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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=@@@&dopt=Abstract true true 17 true IDENTICAL 29231133 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=29231133&dopt=Abstract false true Classification 12215 /api/classification/12215 true true SjrRating 10990185 /api/sjrrating/10990185 3 0.0 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2701 /api/classificationexternal/2701 true 2701 true D1 DIRECT true true /api/publication/30476882 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Mateos María-Victoria ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Dimopoulos Meletios A </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Cavo Michele </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Suzuki Kenshi </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Jakubowiak Andrzej </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Knop Stefan </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Doyen Chantal </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lucio Paulo </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10024022"><a href="/gui2/?type=authors&mode=browse&sel=10024022" target="_blank">Nagy Zsolt (<span class="authorship-author-name">Nagy Zsolt</span> <span class="authorAux-mtmt"> Belgyógyászat, endokrinológia, hematológia</span>) </a> </span> <span class="author-affil">Semmelweis University; <span title="Semmelweis University">SU</span>/<span title="Faculty of Medicine">FM</span>/<span title="Clinical">C</span>/I. Department of Internal Medicine</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kaplan Polina </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Pour Ludek </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Cook Mark </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Grosicki Sebastian </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Crepaldi Andre </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Liberati Anna M </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Campbell Philip </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Shelekhova Tatiana </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Yoon Sung-Soo </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Iosava Genadi </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Fujisaki Tomoaki </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Garg Mamta </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Chiu Christopher </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Wang Jianping </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Carson Robin </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Crist Wendy </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Deraedt William </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Nguyen Huong </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Qi Ming </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >San-Miguel Jesus </span> </div> <div class="autype autype-11"> Collaborator: <span class="author-name" >Fantl Dorotea </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10013001"><a href="/gui2/?type=authors&mode=browse&sel=10013001" target="_blank">Szomor Arpad (<span class="authorship-author-name">Szomor Árpád</span> <span class="authorAux-mtmt"> Hematológia, belgyógyászat</span>) </a> </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10015319"><a href="/gui2/?type=authors&mode=browse&sel=10015319" target="_blank">Masszi Tamas (<span class="authorship-author-name">Masszi Tamás</span> <span class="authorAux-mtmt"> belgyógyászat, hematológia</span>) </a> </span> <span class="author-affil">Semmelweis University</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10048765"><a href="/gui2/?type=authors&mode=browse&sel=10048765" target="_blank">Mikala Gabor (<span class="authorship-author-name">Mikala Gábor</span> <span class="authorAux-mtmt"> Hematológia</span>) </a> </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10006817"><a href="/gui2/?type=authors&mode=browse&sel=10006817" target="_blank">Rosta Andras (<span class="authorship-author-name">Rosta András</span> <span class="authorAux-mtmt"> Onkológia</span>) </a> </span> <span class="author-affil">National Institute of Oncology</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10012336"><a href="/gui2/?type=authors&mode=browse&sel=10012336" target="_blank">Egyed Miklos (<span class="authorship-author-name">Egyed Miklós</span> <span class="authorAux-mtmt"> Hematológia</span>) </a> </span> <span class="author-affil">Somogy Megyei Kaposi Mór Oktató Kórház</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10045995"><a href="/gui2/?type=authors&mode=browse&sel=10045995" target="_blank">Varga Gergely (<span class="authorship-author-name">Varga Gergely</span> <span class="authorAux-mtmt"> hematológia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis University">SU</span>/<span title="Faculty of Medicine">FM</span>/<span title="Clinical">C</span>/III. Department of Internal Medicine</span> ;&nbsp;&nbsp;&nbsp; et al. (212) </div> <div class="autype autype-29"> Collaborative Organization: <span class="author-affil">ALCYONE Trial Investigators</span> </div> <div><a target="_blank" href="/api/publication/30476882?labelLang=eng">All authors</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;30476882" target="_blank">Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma</a></div> <div> <span class="journal-title">NEW ENGLAND JOURNAL OF MEDICINE</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0028-4793">0028-4793</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1533-4406">1533-4406</a>)</span>: <span class="journal-volume">378</span> <span class="journal-issue">6</span> <span class="page"> pp 518-528 </span> <span class="year">(2018)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Language: English | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1056/NEJMoa1714678" target="_blank" href="https://doi.org/10.1056/NEJMoa1714678"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000424335200007" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000424335200007"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85042083059" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85042083059"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="29231133" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=29231133&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Journal subject: Scopus - Medicine (miscellaneous)&nbsp;&nbsp;&nbsp;Rank:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="" class="citingPub-count">Citing papers: 881</span> | Independent citation: 689 | Self citation: 192 | Unknown citation: 0 | Number of citations in WoS: 815 | Number of citations in Scopus:&nbsp;799 | WoS/Scopus assigned:&nbsp;863 | Number of citations with DOI:&nbsp;862 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;30476882&sort=publishedYear,desc&sort=title"> Number of cited publications: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Publication: 30476882</span> | <span class="status-data status-VALIDATED"> Validated </span> Core Citing | <span class="type-subtype">Journal Article ( Study Group ) </span> | <span class="pub-category">Scientific</span> | <span class="publication-sourceOfData">PubMed (pubmedRostaA.xml, 2019-02-27)</span> </div> <div class="lastModified">Last Modified: 2025.10.03. 10:56 Edit Szendrődiné Balogh (Fejér Szt György kh admin4) </div> <div class="lockedBy">Centrally managed 2023.06.05. 17:04 Éva Pécsi (MTMT Közp 2,3, admin) </div> </div></div>