{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T13:08:21Z","timestamp":1789564101101,"version":"build-2803163510"},"reference-count":15,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:00:00Z","timestamp":1789516800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson and Johnson","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In the global phase 3 AQUILA trial, daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death than active monitoring in patients with high-risk smoldering multiple myeloma without unexpected safety concerns (NCT03301220).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Here, we report a subgroup analysis of Japanese patients from the trial. Among the 28 Japanese patients, 15 and 13 patients received daratumumab and active monitoring, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At the median follow-up of 60.9\u00a0months, the median progression-free survival was 59.1 and 24.8\u00a0months, respectively, with a hazard ratio of 0.25 [95% confidence interval (CI): 0.10\u20130.65] favoring daratumumab treatment. The overall response rate was 86.7% and 7.7%, with an odds ratio of 78.0 (95% CI: 6.24\u2013974.71). Overall survival data were immature. Grade\u00a0\u22653 adverse events were observed in five patients (33.3%) treated with daratumumab, which did not lead to treatment discontinuation, and no new safety concerns were noted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this small-scale exploratory post hoc Japanese subgroup analysis, the efficacy of daratumumab monotherapy was generally comparable to that demonstrated in the global trial population, and no data suggesting new safety concerns were identified. These findings may provide useful information for determining treatment options in Japanese patients with high-risk smoldering multiple myeloma.<\/jats:p>\n                    <jats:p>Trial registration number: \u00a0ClinicalTrials.gov number, NCT03301220.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jjco\/hyag146","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T11:51:35Z","timestamp":1787226695000},"source":"Crossref","is-referenced-by-count":0,"title":["Japanese subgroup analysis of AQUILA trial: daratumumab vs active monitoring in high-risk smoldering multiple myeloma"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7132-5337","authenticated-orcid":false,"given":"Kenshi","family":"Suzuki","sequence":"first","affiliation":[{"name":"Department of Hematology, Japanese Red Cross Medical Center , 4-1-22 Hiroo, Shibuya-ku, Tokyo 150-8935 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Kosugi","sequence":"additional","affiliation":[{"name":"Department of Hematology, Central Japan International Medical Center, 1-1 Kenkonomachi, Minokamo, Gifu 505-8510 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiro","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Hematology, NHO Matsumoto Medical Center , 2-20-30 Muraimachi-Minami, Matsumoto, Nagano 399-8701 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Takamatsu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital , 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter M","family":"Voorhees","sequence":"additional","affiliation":[{"name":"Levine Cancer Institute, Atrium Health Wake Forest University School of Medicine , 1021 Morehead Medical Drive, Charlotte, NC 28204 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S Vincent","family":"Rajkumar","sequence":"additional","affiliation":[{"name":"Division of Hematology, Mayo Clinic , Rochester , 200 First Street SW, Rochester, MN 55905,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miku","family":"Ito","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , 3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chika","family":"Sakai","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , 3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marimo","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , 3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiko","family":"Nakatogawa","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , 3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robyn","family":"Dennis","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , 1400 McKean Road, Spring House, PA 19477 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Carson","sequence":"additional","affiliation":[{"name":"Johnson & Johnson , 1400 McKean Road, Spring House, PA 19477 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meletios A","family":"Dimopoulos","sequence":"additional","affiliation":[{"name":"Department of Clinical Therapeutics, Alexandra General Hospital, National and Kapodistrian University of Athens , 80 Vassilissis Sofias Avenue, Athens 115 28 ,","place":["Greece"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,9,16]]},"reference":[{"key":"2026091608144709600_ref1","doi-asserted-by":"publisher","first-page":"3069","DOI":"10.1182\/blood-2014-09-568899","article-title":"Smoldering multiple myeloma","volume":"125","author":"Rajkumar","year":"2015","journal-title":"Blood"},{"key":"2026091608144709600_ref2","doi-asserted-by":"publisher","first-page":"102","DOI":"10.1038\/s41408-020-00366-3","article-title":"International Myeloma Working Group risk stratification model for smoldering multiple myeloma (SMM)","volume":"10","author":"Mateos","year":"2020","journal-title":"Blood Cancer J"},{"key":"2026091608144709600_ref3","doi-asserted-by":"publisher","first-page":"1840","DOI":"10.4049\/jimmunol.1003032","article-title":"Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors","volume":"186","author":"Weers","year":"2011","journal-title":"J Immunol"},{"key":"2026091608144709600_ref4","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1080\/19420862.2015.1007813","article-title":"Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma","volume":"7","author":"Overdijk","year":"2015","journal-title":"MAbs"},{"key":"2026091608144709600_ref5","doi-asserted-by":"publisher","first-page":"384","DOI":"10.1182\/blood-2015-12-687749","article-title":"Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma","volume":"128","author":"Krejcik","year":"2016","journal-title":"Blood"},{"key":"2026091608144709600_ref6","doi-asserted-by":"publisher","first-page":"2104","DOI":"10.1056\/NEJMoa1817249","article-title":"Daratumumab plus lenalidomide and dexamethasone for untreated myeloma","volume":"380","author":"Facon","year":"2019","journal-title":"N Engl J Med"},{"key":"2026091608144709600_ref7","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1002\/cyto.a.23693","article-title":"High-parameter mass cytometry evaluation of relapsed\/refractory multiple myeloma patients treated with daratumumab demonstrates immune modulation as a novel mechanism of action","volume":"95","author":"Adams","year":"2019","journal-title":"Cytometry A"},{"key":"2026091608144709600_ref8","doi-asserted-by":"publisher","first-page":"1840","DOI":"10.1038\/s41375-020-0718-z","article-title":"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS)","volume":"34","author":"Landgren","year":"2020","journal-title":"Leukemia"},{"key":"2026091608144709600_ref9","doi-asserted-by":"publisher","first-page":"1658","DOI":"10.1182\/blood.2024025897","article-title":"Efficacy and safety of daratumumab in intermediate\/high-risk smoldering multiple myeloma: final analysis of CENTAURUS","volume":"145","author":"Landgren","year":"2025","journal-title":"Blood"},{"key":"2026091608144709600_ref10","doi-asserted-by":"publisher","first-page":"1777","DOI":"10.1056\/NEJMoa2409029","article-title":"Daratumumab or active monitoring for high-risk smoldering multiple myeloma","volume":"392","author":"Dimopoulos","year":"2025","journal-title":"N Engl J Med"},{"key":"2026091608144709600_ref11","doi-asserted-by":"publisher","first-page":"e538","DOI":"10.1016\/S1470-2045(14)70442-5","article-title":"International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma","volume":"15","author":"Rajkumar","year":"2014","journal-title":"Lancet Oncol"},{"key":"2026091608144709600_ref12","doi-asserted-by":"publisher","first-page":"4691","DOI":"10.1182\/blood-2010-10-299487","article-title":"Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1","volume":"117","author":"Rajkumar","year":"2011","journal-title":"Blood"},{"key":"2026091608144709600_ref13","doi-asserted-by":"publisher","first-page":"1188","DOI":"10.1111\/j.0006-341x.1999.01188.x","article-title":"Closed testing procedures for group sequential clinical trials with multiple endpoints","volume":"55","author":"Tang","year":"1999","journal-title":"Biometrics"},{"key":"2026091608144709600_ref14","doi-asserted-by":"publisher","first-page":"59","DOI":"10.1038\/s41408-018-0077-4","article-title":"Risk stratification of smoldering multiple myeloma incorporating revised IMWG diagnostic criteria","volume":"8","author":"Lakshman","year":"2018","journal-title":"Blood Cancer J"},{"key":"2026091608144709600_ref15","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1038\/s41408-024-01170-z","article-title":"Real-world characteristics and outcomes of patients with high-risk and non-high-risk smoldering multiple myeloma using the Flatiron Health database","volume":"14","author":"Rajkumar","year":"2024","journal-title":"Blood Cancer J"}],"container-title":["Japanese Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jjco\/advance-article-pdf\/doi\/10.1093\/jjco\/hyag146\/71122458\/hyag146.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jjco\/advance-article-pdf\/doi\/10.1093\/jjco\/hyag146\/71122458\/hyag146.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T12:14:58Z","timestamp":1789560898000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jjco\/advance-article\/doi\/10.1093\/jjco\/hyag146\/8802019"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,16]]},"references-count":15,"URL":"https:\/\/doi.org\/10.1093\/jjco\/hyag146","relation":{},"ISSN":["1465-3621"],"issn-type":[{"value":"1465-3621","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,16]]},"article-number":"hyag146"}}