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The efficacy analysis (<jats:italic>n<\/jats:italic>\u2009=\u2009167) showed that isatuximab 20\u00a0mg\/kg monotherapy was effective in the treatment of individuals with RRMM, with an overall response rate (ORR) of 26.3%, a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 20.2 months. Isatuximab demonstrated rapid and sustained efficacy when used as monotherapy, with a median time to response of 1.0 month and a median duration of response of 10.3 months. The safety analysis, which included 477 participants from four clinical trials, showed that isatuximab had an acceptable safety profile that was consistent across all the dose groups examined. The most common treatment-emergent adverse events were infusion reactions (in 45.7% of participants), most of which were of grade 1 or 2 severity and occurred during the first infusion. Overall, no safety concerns were identified. In addition, participants aged\u2009\u2265\u200975 years had higher ORR and longer PFS and OS than those aged\u2009&lt;\u200965 years, and since the proportions of patients with an Eastern Cooperative Oncology Group performance status of 2 did not vary significantly by age group, it appears that age does not affect the efficacy and safety of isatuximab treatment in RRMM. Further research is warranted to elaborate upon these findings.<\/jats:p>","DOI":"10.1007\/s00277-025-06343-9","type":"journal-article","created":{"date-parts":[[2025,4,21]],"date-time":"2025-04-21T03:27:37Z","timestamp":1745206057000},"page":"2337-2350","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy and safety of isatuximab monotherapy to treat relapsed or refractory multiple myeloma: a pooled analysis of clinical trials"],"prefix":"10.1007","volume":"104","author":[{"given":"Meletios","family":"Dimopoulos","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazutaka","family":"Sunami","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xavier","family":"Leleu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ravi","family":"Vij","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Gasparetto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandrine","family":"Mac\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keisuke","family":"Tada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mutsumi","family":"Hirakawa","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":[[2025,4,21]]},"reference":[{"key":"6343_CR1","doi-asserted-by":"publisher","first-page":"676","DOI":"10.1053\/j.seminoncol.2016.11.004","volume":"43","author":"D Kazandjian","year":"2016","unstructured":"Kazandjian D (2016) Multiple myeloma epidemiology and survival: a unique malignancy. 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KS: has received honoraria from Bristol-Myers Squibb, Janssen Pharmaceuticals, Ono Pharmaceutical and Sanofi, and research funding from AbbVie GK, Bristol-Myers Squibb, Celgene Corporation, Chugai Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., Janssen Pharmaceuticals, Kyowa Kirin, MSD, Novartis, Ono Pharmaceutical, Otsuka Pharmaceutical, Pfizer Japan Inc., Sanofi and Takeda. XL: has for received consulting fees, support for attending meetings and\/or travel, honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing or educational events, and has participated on a data safety monitoring board or advisory board of Sanofi. RV: has received honoraria from Bristol-Myers Squibb, Janssen Pharmaceuticals, Karyopharm, Pfizer, Regeneron Pharmaceuticals and Sanofi, and grant support from Bristol-Myers Squibb, Sanofi and Takeda. CG: has received clinical trial\/contracts with Bristol-Myers Squibb, Karyopharm, AbbVie, Caribou and K36 Therapeutics; honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing or educational events from Bristol-Myers Squibb, Karyopharm and Sanofi; support for attending meetings and\/or travel from Sanofi; participated on a data safety monitoring board or advisory board for Bristol-Myers Squibb, GlaxoSmithKline K.K., Pfizer and Janssen Pharmaceuticals; and has a leadership or fiduciary role in Bristol-Myers Squibb. KS: has received lecture fees from Bristol-Myers Squibb Takeda, Ono Pharmaceutical, Novartis, Sanofi, AbbVie and Janssen. SM and KT are employees of Sanofi. MH is employee and has stock of Sanofi. SI: has received honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing or educational events from Astra Zeneca, Bristol-Myers Squibb, Janssen, Ono, Pfizer, Sanofi and Takeda; consulting fees from AbbVie GK, Bristol-Myers Squibb, GlaxoSmithKline K.K., Janssen Pharmaceuticals K.K., Novartis, Pfizer, Sanofi KK and Takeda Pharmaceutical Co., Ltd.; research grants from AbbVie GK, Amgen K.K., Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Limited, GlaxoSmithKline K.K., Janssen Pharmaceutical K.K., Novartis, Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi K.K., Shionogi & Co., Ltd. and Takeda Pharmaceutical Co., Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}