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This open\u2010label, single\u2010arm, multicenter, phase 1\/2 trial investigated the tolerability\/safety and efficacy of isatuximab monotherapy in Japanese patients with heavily pretreated, relapsed\/refractory multiple myeloma (RRMM). In Phase 1, patients were sequentially assigned to receive isatuximab once weekly (QW) in cycle 1 (4\u00a0weeks) and every 2\u00a0weeks (Q2W) in subsequent cycles. Cohort 1 (n\u00a0=\u00a03) received 10\u00a0mg\/kg QW\/Q2W; cohort 2 (n\u00a0=\u00a05) received 20\u00a0mg\/kg QW\/Q2W. No dose\u2010limiting toxicities occurred; the recommended dose for the single\u2010arm phase 2 study (n\u00a0=\u00a028) was 20\u00a0mg\/kg QW\/Q2W. The overall safety profile was consistent with the current knowledge of isatuximab. The most common adverse events were infusion reactions (42.9%; 12\/28); all were grade 1\/2 and generally occurred during the first infusion. The overall response rate with 20\u00a0mg\/kg QW\/Q2W isatuximab was 36.4% (12\/33); patients with high\u2010risk cytogenetic abnormalities had comparable results. In phase 2, the median progression\u2010free survival was 4.7 (95% confidence interval, 3.75 to not reached) months. Median overall survival was not reached. Isatuximab monotherapy was well tolerated and effective in patients with heavily pretreated RRMM including high\u2010risk cytogenetic patients. This trial is registered at ClinicalTrials.gov as NCT02812706.<\/jats:p>","DOI":"10.1111\/cas.14657","type":"journal-article","created":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T14:12:46Z","timestamp":1601043166000},"page":"4526-4539","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Isatuximab monotherapy in relapsed\/refractory multiple myeloma: A Japanese, multicenter, phase 1\/2, safety and efficacy study"],"prefix":"10.1111","volume":"111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8229-7439","authenticated-orcid":false,"given":"Kazutaka","family":"Sunami","sequence":"first","affiliation":[{"name":"Department of Hematology National Hospital Organization Okayama Medical Center Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Myeloma\/Amyloidosis Center Japanese Red Cross Medical Center Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9617-486X","authenticated-orcid":false,"given":"Masaki","family":"Ri","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Nagoya City University Institute of Medical and Pharmaceutical Sciences Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morio","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Shibukawa Medical Center Shibukawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chihiro","family":"Shimazaki","sequence":"additional","affiliation":[{"name":"Department of Hematology Japan Community Health care Organization Kyoto Kuramaguchi Medical Center Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Asaoku","sequence":"additional","affiliation":[{"name":"Department of Hematology Hiroshima Red Cross Hospital and Atomic\u2010bomb Survivors Hospital Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirohiko","family":"Shibayama","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Ishizawa","sequence":"additional","affiliation":[{"name":"Department of Third Internal Medicine, Division of Hematology and Cell Therapy Yamagata University Faculty of Medicine Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Takamatsu","sequence":"additional","affiliation":[{"name":"Department of Hematology Faculty of Medicine Institute of Medical, Pharmaceutical and Health Sciences Kanazawa University Kanazawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Division of Hematology and Stem Cell Transplantation Shizuoka Cancer Center Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0654-6920","authenticated-orcid":false,"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[{"name":"Department of Hematology National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitomi","family":"Kaneko","sequence":"additional","affiliation":[{"name":"Department of Hematology Japanese Red Cross Osaka Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michihiro","family":"Uchiyama","sequence":"additional","affiliation":[{"name":"Department of Hematology Japanese Red Cross Society Suwa Hospital Suwa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Kiguchi","sequence":"additional","affiliation":[{"name":"Department of Hematology Chugoku Central Hospital Fukuyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Iyama","sequence":"additional","affiliation":[{"name":"Department of Hematology Sapporo Medical University School of Medicine Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirokazu","family":"Murakami","sequence":"additional","affiliation":[{"name":"Department of Laboratory Sciences Gunma University Graduate School of Health Sciences Maebashi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keishiro","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Research and Development Sanofi K.K. 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