{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T19:18:57Z","timestamp":1772047137804,"version":"3.50.1"},"reference-count":37,"publisher":"American Society of Hematology","issue":"12","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2019,6,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Daratumumab (DARA) has shown impressive activity in combination with other agents for the treatment of multiple myeloma (MM). We conducted a phase 1b study to assess the safety and preliminary efficacy, as well as potential mechanisms of action, of DARA (16 mg\/kg) in combination with a weekly schedule of subcutaneous bortezomib (1.3-1.5 mg\/m2), cyclophosphamide (150-300 mg\/m2), and dexamethasone (40 mg) (CyBorD DARA) as initial induction before autologous stem cell transplantation (ASCT). Eligible patients were \u226470 years of age with untreated MM requiring treatment and who lacked significant comorbidities. A total of 18 patients were enrolled. Their median age was 56 years (range, 32-66 years), and all patients had Eastern Cooperative Oncology Group performance status \u22641. The International Staging System stages were I, II, and III in 78%, 17%, and 6% of patients, respectively; 28% of patients had high-risk genetic features. There was no dose-limiting toxicity, and the incidence of grade 3 or 4 infection or neutropenia was &amp;lt;10%. On an intention-to-treat basis, 94% achieved \u2265very good partial response with \u2265complete response in 44% of patients. Among 14 of 15 patients who underwent ASCT and were evaluable for response, all 14 achieved at least very good partial response, with 8 (57%) of 14 achieving complete response. After ASCT, 10 (83%) of 12 patients in whom minimal residual disease analysis was possible were negative at a sensitivity of 10\u22125 (56% on intention-to-treat\/whole study population) according to next-generation sequencing. Flow cytometry analysis of patient samples indicated CyBorD DARA induced activation of macrophage-mediated antibody-dependent cellular phagocytosis. This trial was registered at www.clinicaltrials.gov as #NCT02955810.<\/jats:p>","DOI":"10.1182\/bloodadvances.2019000010","type":"journal-article","created":{"date-parts":[[2019,6,14]],"date-time":"2019-06-14T16:45:24Z","timestamp":1560530724000},"page":"1815-1825","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":19,"title":["CyBorD-DARA is potent initial induction for MM and enhances ADCP: initial results of the 16-BCNI-001\/CTRIAL-IE 16-02 study"],"prefix":"10.1182","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6173-7140","authenticated-orcid":false,"given":"M.","family":"O\u2019Dwyer","sequence":"first","affiliation":[{"name":"Department of Hematology, University Hospital Galway, Galway, Ireland;"},{"name":"Blood Cancer Network Ireland, Galway, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"Henderson","sequence":"additional","affiliation":[{"name":"Department of Hematology, University Hospital Galway, Galway, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. 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R.","family":"Cahill","sequence":"additional","affiliation":[{"name":"CancerResearch at UCC, University College Cork, Cork, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P.","family":"Murphy","sequence":"additional","affiliation":[{"name":"Department of Hematology, Beaumont Hospital, Dublin, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9937-4306","authenticated-orcid":false,"given":"V.","family":"Mykytiv","sequence":"additional","affiliation":[{"name":"Department of Hematology, Cork University Hospital, Cork, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Quinn","sequence":"additional","affiliation":[{"name":"Department of Hematology, Beaumont Hospital, Dublin, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"McEllistrim","sequence":"additional","affiliation":[{"name":"Department of Hematology, University Hospital Galway, Galway, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Krawczyk","sequence":"additional","affiliation":[{"name":"Department of Hematology, University Hospital Galway, Galway, Ireland;"},{"name":"Blood Cancer Network Ireland, Galway, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Walsh","sequence":"additional","affiliation":[{"name":"Blood Cancer Network Ireland, Galway, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Lenihan","sequence":"additional","affiliation":[{"name":"Department of Hematology, Cork University Hospital, Cork, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Kenny","sequence":"additional","affiliation":[{"name":"Department of Hematology, Beaumont Hospital, Dublin, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Hernando","sequence":"additional","affiliation":[{"name":"Cancer Trials Ireland, Dublin, Ireland; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Hirakata","sequence":"additional","affiliation":[{"name":"Cancer Trials Ireland, Dublin, Ireland; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I.","family":"Parker","sequence":"additional","affiliation":[{"name":"Cancer Trials Ireland, Dublin, Ireland; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Kinsella","sequence":"additional","affiliation":[{"name":"Cancer Trials Ireland, Dublin, Ireland; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G.","family":"Gannon","sequence":"additional","affiliation":[{"name":"Blood Cancer Network Ireland, Galway, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4321-9005","authenticated-orcid":false,"given":"A.","family":"Natoni","sequence":"additional","affiliation":[{"name":"Biomedical Sciences, National University of Ireland Galway, Galway, Ireland;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Lynch","sequence":"additional","affiliation":[{"name":"Biomedical Sciences, National University of Ireland Galway, Galway, Ireland;"},{"name":"Discipline of Pharmacology & Therapeutics, School of Medicine, College of Medicine, Nursing, and Health Sciences, National University of Ireland Galway, Galway, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A. 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