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Patients who had received\u2009\u2265\u20092 prior lines of therapy including a proteasome inhibitor and immunomodulatory agent were eligible. Eight patients received belantamab mafodotin monotherapy at 2.5\u00a0mg\/kg (n\u2009=\u20094) or 3.4\u00a0mg\/kg (n\u2009=\u20094) by intravenous infusion every 3\u00a0weeks on day 1 of each cycle until disease progression or unacceptable toxicity. Primary objectives were tolerability and safety, and secondary objectives included pharmacokinetics (PK) and efficacy. The most common Grade\u2009\u2265\u20093 adverse event was thrombocytopenia\/platelet count decreased (2.5\u00a0mg\/kg cohort, 100% [4\/4]; 3.4\u00a0mg\/kg cohort, 75% [3\/4]), and no dose-limiting toxicities were observed. Ocular events, including keratopathy findings, were observed in most patients (2.5\u00a0mg\/kg cohort, 100% [4\/4]; 3.4\u00a0mg\/kg cohort, 75% [3\/4]) and were managed with dose modifications. All resolved within the study period. Overall response rates were 50% (2\/4) in the 2.5\u00a0mg\/kg cohort and 25% (1\/4) in the 3.4\u00a0mg\/kg cohort. Although PK profiles in Japanese patients varied, individual exposures overlapped with previous results in Western populations. Belantamab mafodotin monotherapy was generally well-tolerated and demonstrated clinical activity at both doses.<\/jats:p>","DOI":"10.1007\/s12185-023-03652-5","type":"journal-article","created":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T12:02:27Z","timestamp":1693915347000},"page":"596-608","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety, pharmacokinetics, and efficacy of belantamab mafodotin monotherapy in Japanese patients with relapsed or refractory multiple myeloma: DREAMM-11"],"prefix":"10.1007","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4951-960X","authenticated-orcid":false,"given":"Shinsuke","family":"Iida","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazutaka","family":"Sunami","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuko","family":"Mishima","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":"Takumi","family":"Terao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuki","family":"Matsuzawa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mari","family":"Matsubara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy","family":"Crossman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brandon E.","family":"Kremer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ira","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,9,5]]},"reference":[{"key":"3652_CR1","doi-asserted-by":"publisher","first-page":"17046","DOI":"10.1038\/nrdp.2017.46","volume":"3","author":"SK Kumar","year":"2017","unstructured":"Kumar SK, Rajkumar V, Kyle RA, van Duin M, Sonneveld P, Mateos MV, et al. 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K.S. reports research funding from Ono, MSD, Celgene, AbbVie, Takeda, Sanofi, Bristol-Myers Squibb, Daiichi-Sankyo, Janssen, Novartis, Alexion, GSK, Chugai, Otsuka, and Astellas-Amgen and honoraria from Ono, Celgene, Takeda, Bristol-Myers Squibb, Sanofi, and Janssen outside the submitted work. Y.M. reports consulting fees from Chugai Roche; research funding from Takeda, Bristol-Myers Squibb, E-sai, Taiho, and Kyowa-Kirin. T.F. reports employment and ownership interest from GSK outside the submitted work. H.K. reports employment from GSK outside the submitted work. T.T. was an employee of GSK at time of study and reported ownership interest from GSK outside the submitted work. Y.M. was an employee of GSK at time of study. M.M. reports employment and ownership interest from GSK outside the submitted work. T.C. reports employment and ownership interest from GSK outside the submitted work. B.E.K. reports employment and ownership interest from GSK outside the submitted work. I.G. was an employee of GSK at time of study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict 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"}}]}}