{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T06:41:28Z","timestamp":1740120088300,"version":"3.37.3"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T00:00:00Z","timestamp":1734998400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T00:00:00Z","timestamp":1734998400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"GSK"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:p>DREAMM-11 (NCT03828292) was a Phase 1, open-label, dose-escalation study of belantamab mafodotin in Japanese patients with relapsed\/refractory multiple myeloma (RRMM). In Part 1, belantamab mafodotin monotherapy (2.5 or 3.4\u00a0mg\/kg every 3\u00a0weeks) was tolerated and demonstrated clinical activity and a manageable safety profile. Part 2 investigated the tolerability, safety, clinical activity and pharmacokinetics of belantamab mafodotin (2.5\u00a0mg\/kg on Day [D]1 of each 21-day cycle) plus bortezomib and dexamethasone (Arm A; N\u2009=\u20093) or belantamab mafodotin (2.5\u00a0mg\/kg on D1 of the first 28-day cycle; 1.9\u00a0mg\/kg on D1 of subsequent cycles) plus pomalidomide and dexamethasone (Arm B; N\u2009=\u20094) in Japanese patients with RRMM and\u2009\u2265\u20091 prior line of therapy. No dose-limiting toxicities were reported in Arm A; 1 (non-serious liver injury) was reported in Arm B. Safety profiles of each treatment combination were consistent with those of the individual agents and those in Western populations. An overall response was achieved by 3\/3 (100%) patients in Arm A and 2\/4 (50%) in Arm B. Pharmacokinetics were consistent between Japanese and Western populations. The clinical pharmacokinetics, safety, and efficacy data from this study can inform future use of belantamab mafodotin plus bortezomib\/pomalidomide and dexamethasone in Japanese patients with RRMM.<\/jats:p>","DOI":"10.1007\/s12185-024-03889-8","type":"journal-article","created":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T05:21:46Z","timestamp":1735017706000},"page":"174-186","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["DREAMM-11, Part 2: Japanese phase I trial of belantamab mafodotin combination therapies in relapsed\/refractory multiple myeloma"],"prefix":"10.1007","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8229-7439","authenticated-orcid":false,"given":"Kazutaka","family":"Sunami","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinsuke","family":"Iida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuhiro","family":"Tsukada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taku","family":"Fujii","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hitomi","family":"Kato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryuichi","family":"Fukushima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Wakabayashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirofumi","family":"Nakano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sumita","family":"Roy-Ghanta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brandon E.","family":"Kremer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,12,24]]},"reference":[{"issue":"18","key":"3889_CR1","doi-asserted-by":"publisher","first-page":"4088","DOI":"10.3390\/jcm10184088","volume":"10","author":"M Kleber","year":"2021","unstructured":"Kleber M, Ntanasis-Stathopoulos I, Terpos E. BCMA in multiple myeloma-a promising key to therapy. J Clin Med. 2021;10(18):4088.","journal-title":"J Clin Med"},{"issue":"5","key":"3889_CR2","doi-asserted-by":"publisher","first-page":"758","DOI":"10.1002\/cncr.29119","volume":"121","author":"EE Kent","year":"2015","unstructured":"Kent EE, Ambs A, Mitchell SA, Clauser SB, Smith AW, Hays RD. Health-related quality of life in older adult survivors of selected cancers: data from the SEER-MHOS linkage. Cancer. 2015;121(5):758\u201365.","journal-title":"Cancer"},{"issue":"20","key":"3889_CR3","doi-asserted-by":"publisher","first-page":"3128","DOI":"10.1182\/blood-2013-10-535088","volume":"123","author":"YT Tai","year":"2014","unstructured":"Tai YT, Mayes PA, Acharya C, Zhong MY, Cea M, Cagnetta A, et al. Novel anti-B-cell maturation antigen antibody-drug conjugate (GSK2857916) selectively induces killing of multiple myeloma. 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Lancet Haematol. 2023;10(10):e801\u201312.","journal-title":"Lancet Haematol"},{"issue":"2","key":"3889_CR6","doi-asserted-by":"publisher","first-page":"207","DOI":"10.1016\/S1470-2045(19)30788-0","volume":"21","author":"S Lonial","year":"2020","unstructured":"Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020;21(2):207\u201321.","journal-title":"Lancet Oncol"},{"issue":"36 Suppl","key":"3889_CR7","doi-asserted-by":"publisher","first-page":"439572","DOI":"10.1200\/JCO.2024.42.36_suppl.439572","volume":"42","author":"MV Mateos","year":"2024","unstructured":"Mateos MV, Robak P, Hus M, Xia Z, Zherebtsova V, Ward C, et al. Results from the randomized phase III DREAMM-7 study of belantamab mafodotin (belamaf) + bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed\/refractory multiple myeloma (RRMM). J Clin Oncol. 2024;42(36 Suppl):439572.","journal-title":"J Clin Oncol"},{"key":"3889_CR8","doi-asserted-by":"publisher","first-page":"543","DOI":"10.1038\/s41591-023-02703-y","volume":"30","author":"S Trudel","year":"2024","unstructured":"Trudel S, McCurdy A, Louzada ML, Parkin S, White D, Chu MP, et al. Belantamab mafodotin, pomalidomide and dexamethasone in refractory multiple myeloma: a phase 1\/2 trial. Nat Med. 2024;30:543\u201351.","journal-title":"Nat Med"},{"key":"3889_CR9","doi-asserted-by":"publisher","first-page":"408","DOI":"10.1056\/NEJMoa2403407","volume":"391","author":"MA Dimopoulos","year":"2024","unstructured":"Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, et al. 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Antibody-drug conjugate, GSK2857916, in relapsed\/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study. Blood Cancer J. 2019;9(4):37.","journal-title":"Blood Cancer J"},{"key":"3889_CR15","unstructured":"Millennium Pharmaceuticals Inc. Velcade (Bortezomib) Prescribing Information. Revised 2014. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2014\/021602s040lbl.pdf. Accessed 30 May 2024."}],"container-title":["International Journal of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-024-03889-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12185-024-03889-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-024-03889-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,30]],"date-time":"2025-01-30T16:35:08Z","timestamp":1738254908000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12185-024-03889-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,24]]},"references-count":15,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["3889"],"URL":"https:\/\/doi.org\/10.1007\/s12185-024-03889-8","relation":{},"ISSN":["0925-5710","1865-3774"],"issn-type":[{"type":"print","value":"0925-5710"},{"type":"electronic","value":"1865-3774"}],"subject":[],"published":{"date-parts":[[2024,12,24]]},"assertion":[{"value":"17 June 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 November 2024","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 November 2024","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 December 2024","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"KS reports research funding from Ono, MSD, Celgene, AbbVie, Takeda, Sanofi, Bristol-Myers Squibb, Janssen, Novartis, GSK, Chugai, Otsuka, Kyowa Kirin and Pfizer, and honoraria from Ono, Bristol-Myers Squibb, Sanofi and Janssen outside the submitted work. SI reports research funding from Ono, AbbVie, Takeda, Sanofi, Bristol-Myers Squibb, Daiichi-Sankyo, Janssen, Novartis, GSK, Chugai, Pfizer, Amgen and Shionogi, and honoraria from Takeda, Bristol-Myers Squibb, Sanofi, Pfizer, AstraZeneca and Janssen outside the submitted work. TF reports employment and ownership interest from GSK outside the submitted work. HK reports employment from GSK outside the submitted work. RF reports employment from GSK outside the submitted work. SW reports employment from GSK outside the submitted work. HN reports employment and ownership interest from GSK outside the submitted work. SRG reports employment from and financial equities in GSK outside the submitted work. BEK reports employment from and financial equities in GSK outside the submitted work.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The study was done in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines following approval by ethics committees and institutional review boards at each study site. All patients provided written informed consent. This trial is registered at ClinicalTrials.gov (), identification number NCT03828292.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}