{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T07:54:04Z","timestamp":1790409244884,"version":"4.1.0"},"reference-count":24,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,7,30]],"date-time":"2020-07-30T00:00:00Z","timestamp":1596067200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development, LLC","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Janssen Global Services, LLC"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Daratumumab is a CD38\u2010targeting monoclonal antibody approved for intravenous (IV) infusion for multiple myeloma (MM). We describe the Phase II PLEIADES study of a subcutaneous formulation of daratumumab (DARA SC) in combination with standard\u2010of\u2010care regimens: DARA SC plus bortezomib\/lenalidomide\/dexamethasone (D\u2010VRd) for transplant\u2010eligible newly diagnosed MM (NDMM); DARA SC plus bortezomib\/melphalan\/prednisone (D\u2010VMP) for transplant\u2010ineligible NDMM; and DARA SC plus lenalidomide\/dexamethasone (D\u2010Rd) for relapsed\/refractory MM. In total, 199 patients were treated (D\u2010VRd, <jats:italic>n\u00a0<\/jats:italic>=\u00a067; D\u2010VMP, <jats:italic>n<\/jats:italic>\u00a0=\u00a067; D\u2010Rd, <jats:italic>n<\/jats:italic>\u00a0=\u00a065). The primary endpoints were met for all cohorts: the \u2265very good partial response (VGPR) rate after four 21\u2010day induction cycles for D\u2010VRd was 71\u00b76% [90% confidence interval (CI) 61\u00b72\u201380\u00b76%], and the overall response rates (ORRs) for D\u2010VMP and D\u2010Rd were 88\u00b71% (90% CI 79\u00b75\u201393\u00b79%) and 90\u00b78% (90% CI 82\u00b76\u201395\u00b79%). With longer median follow\u2010up for D\u2010VMP and D\u2010Rd (14\u00b73 and 14\u00b77\u00a0months respectively), responses deepened (ORR: 89\u00b76%, 93\u00b78%; \u2265VGPR: 77\u00b76%, 78\u00b75%), and minimal residual disease\u2013negativity (10<jats:sup>\u20125<\/jats:sup>) rates were 16\u00b74% and 15\u00b74%. Infusion\u2010related reactions across all cohorts were infrequent (\u22649\u00b70%) and mild. The median DARA SC administration time was 5\u00a0min. DARA SC with standard\u2010of\u2010care regimens demonstrated comparable clinical activity to DARA IV\u2013containing regimens, with low infusion\u2010related reaction rates and reduced administration time.<\/jats:p>","DOI":"10.1111\/bjh.16980","type":"journal-article","created":{"date-parts":[[2020,7,31]],"date-time":"2020-07-31T05:30:20Z","timestamp":1596173420000},"page":"869-878","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":59,"title":["Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open\u2010label Phase II study"],"prefix":"10.1111","volume":"192","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0405-7480","authenticated-orcid":false,"given":"Ajai","family":"Chari","sequence":"first","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula","family":"Rodriguez\u2010Otero","sequence":"additional","affiliation":[{"name":"Cl\u00ednica Universidad de Navarra\u2010CIMA IDISNA, CIBERONC Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"McCarthy","sequence":"additional","affiliation":[{"name":"Royal Bournemouth Hospital Bournemouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Hematology Japanese Red Cross Medical Center Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vania","family":"Hungria","sequence":"additional","affiliation":[{"name":"Clinica Medica S\u00e3o Germano S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1238-6970","authenticated-orcid":false,"given":"Anna","family":"Sureda Balari","sequence":"additional","affiliation":[{"name":"Hematology Department Institut Catal\u00e0 d'Oncologia \u2013 Hospitalet IDIBELL University of Barcelona Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurore","family":"Perrot","sequence":"additional","affiliation":[{"name":"CHU de Toulouse IUCT\u2010O Universit\u00e9 de Toulouse UPS Service d'H\u00e9matologie Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyrille","family":"Hulin","sequence":"additional","affiliation":[{"name":"Department of Hematology H\u00f4pital Haut L\u00e9v\u00eaque University Hospital Pessac France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3990-394X","authenticated-orcid":false,"given":"Hila","family":"Magen","sequence":"additional","affiliation":[{"name":"Department of Hematology Chaim Sheba Medical Center Ramat\u2010Gan, Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinsuke","family":"Iida","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Nagoya City University Graduate School of Medical Sciences Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladimir","family":"Maisnar","sequence":"additional","affiliation":[{"name":"4th Department of Medicine \u2013 Haematology Charles University Hospital Hradec Kr\u00e1lov\u00e9 Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lionel","family":"Karlin","sequence":"additional","affiliation":[{"name":"Department of Hematology Centre Hospitalier Lyon Sud Hospices Civils de Lyon Pierre\u2010B\u00e9nite France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludek","family":"Pour","sequence":"additional","affiliation":[{"name":"University Hospital Brno Brno Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3072-1784","authenticated-orcid":false,"given":"Dolly A.","family":"Parasrampuria","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; 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