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Data from 211 individuals with RRMM treated with Isa-Pd in Japan between October 2020 and October 2021 were collected, with follow-up for up to 12 months after initiation of Isa-Pd or until treatment discontinuation. The incidence of adverse drug reactions (ADRs), ADRs of special interest (infusion reactions, bone marrow suppression, infections, cardiac disorders, other ADRs of Grade\u2009\u2265\u20093), and serious ADRs was assessed. Best overall response and overall response rate (ORR) were determined. In the safety analysis set (n\u2009=\u2009120), ADR incidence was 57.5%. Most ADRs were hematologic, and serious ADRs occurred in 28.3%. Bone marrow suppression occurred in 46.7% of participants (19.2% serious), infusion reactions in 18.3% (6.7% serious), infections in 11.7% (8.3% serious), and a serious cardiac disorder in one participant; other Grade\u2009\u2265\u20093 ADRs were reported in 3.3% (1.7% serious). In the effectiveness analysis set (n\u2009=\u2009108), the most common best overall response was very good partial response (24.1%), and ORR was 51.9%. These findings support the safety and effectiveness of Isa-Pd for RRMM in real-life settings in Japan.<\/jats:p>","DOI":"10.1007\/s12185-024-03800-5","type":"journal-article","created":{"date-parts":[[2024,5,29]],"date-time":"2024-05-29T19:01:43Z","timestamp":1717009303000},"page":"217-228","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Isatuximab with pomalidomide-dexamethasone in relapsed\/refractory multiple myeloma: post-marketing surveillance in Japan"],"prefix":"10.1007","volume":"120","author":[{"given":"Nami","family":"Tagami","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michihiro","family":"Uchiyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heigoroh","family":"Shirai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Seto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Nishina","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4951-960X","authenticated-orcid":false,"given":"Shinsuke","family":"Iida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,5,29]]},"reference":[{"key":"3800_CR1","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1146\/annurev-pathol-011110-130249","volume":"6","author":"KC Anderson","year":"2011","unstructured":"Anderson KC, Carrasco RD. 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Ltd., Janssen Pharmaceutical K.K., Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb K.K., and Pfizer Japan Inc.; trust research\/joint research funds from Sanofi K.K., Takeda Pharmaceutical Co. Ltd., Janssen Pharmaceutical K.K., Ono Pharmaceutical Co. Ltd., Bristol-Myers Squibb K.K., Pfizer Japan Inc., Daiichi Sankyo Co. Ltd., Amgen K.K., AbbVie GK, Caelum, Shionogi & Co. Ltd., GlaxoSmithKline K.K., and Celgene; and scholarship funds from Chugai Pharmaceutical Co. Ltd. Kenshi Suzuki has received lecture fees from Takeda Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Amgen K.K., Novartis Pharma K.K., Sanofi K.K., Bristol-Myers Squibb K.K., AbbVie GK, and Janssen Pharmaceutical K.K.; consultancy fees from Amgen K.K., Takeda Pharmaceutical Co. Ltd., and Bristol-Myers Squibb K.K.; and trust research\/joint research funds from Bristol-Myers Squibb K.K. Nami Tagami, Heigoroh Shirai, Takeshi Seto and Satoshi Nishina are employees of Sanofi K.K. Satoshi Nishina holds stock in Sanofi. Michihiro Uchiyama has no conflicts of interest to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}