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P plus low-dose dexamethasone (LD-DXM) was evaluated\n                    <jats:italic>versus<\/jats:italic>\n                    LD-DXM alone in patients with relapsed\/refractory multiple myeloma (r\/r MM) in the randomized phase III ADMYRE trial. In absence of a randomized study with P\u2009+\u2009LD-DXM vs. POM\u2009+\u2009LD-DXM, a direct matched comparison between P\u2009+\u2009LD-DXM (ADMYRE data) and pomalidomide (POM)\u2009+\u2009LD-DXM as an External Control Arm (ECA) was conducted using individual patient-level data from several contemporary POM\u2009+\u2009LD-DXM trials with a similar design. A first analysis (ECA1) showed that P\u2009+\u2009LD-DXM was non-inferior to POM\u2009+\u2009LD-DXM in terms of median overall survival (OS): 11.8 vs. 13.9 months; HR\u2009=\u20091.009 (95%CI, 0.812\u20131.254;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.9336). Safety profile showed a lower rate of grade\u2009\u2265\u20093 hematological treatment-related adverse events (TRAEs) (neutropenia 2.5% vs. 37.1%; thrombocytopenia 2.5% vs. 13.2%) and infections (8.1% vs. 18.7%) for P\u2009+\u2009LD-DXM, and a higher rate of grade\u2009\u2265\u20091 gastrointestinal TRAEs (52.8% vs. 27.4%), grade\u2009\u2265\u20093 blood creatine phosphokinase (14.3% v\n                    <jats:italic>s.<\/jats:italic>\n                    0%) and grade\u2009\u2265\u20093 myalgia (5.6% vs. 0%). A second analysis (ECA2) compared POM\u2009+\u2009LD-DXM with the LD-DXM alone arm included in ADMYRE and showed a treatment effect in OS (HR\u2009=\u20090.762; 95%CI, 0.566\u20131.026) similar to that observed in ADMYRE (HR\u2009=\u20090.797, 95%CI, 0.596\u20131.067). Safety profile of POM\u2009+\u2009LD-DXM was associated to a higher rate of TRAEs, as expected for a combination. In conclusion, P\u2009+\u2009LD-DXM can be an alternative therapeutic option in r\/r MM as this comparison shows that P\u2009+\u2009LD-DXM is non-inferior in OS to POM\u2009+\u2009LD-DXM with an advantageous safety profile in terms of hematological and infection events.\n                  <\/jats:p>","DOI":"10.1007\/s00277-026-06811-w","type":"journal-article","created":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T01:14:13Z","timestamp":1768612453000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Plitidepsin in combination with dexamethasone (ADMYRE trial) versus an external control arm of pomalidomide plus dexamethasone in patients with relapsed\/refractory multiple myeloma"],"prefix":"10.1007","volume":"105","author":[{"given":"Heinz","family":"Ludwig","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos","family":"Terpos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Boccadoro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Mart\u00ednez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Kahatt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Jim\u00e9nez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Nieto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Extremera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"G\u00f3mez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicente","family":"Alfaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruthanna","family":"Davi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang","family":"Yin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Victoria","family":"Mateos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,17]]},"reference":[{"issue":"13","key":"6811_CR1","doi-asserted-by":"publisher","first-page":"5216","DOI":"10.1158\/0008-5472.CAN-07-5725","volume":"68","author":"CS Mitsiades","year":"2008","unstructured":"Mitsiades CS, Ocio EM, Pandiella A, Maiso P, Gajate C, Garayoa M, Vilanova D, Montero JC, Mitsiades N, McMullan CJ, Munshi NC, Hideshima T, Chauhan D, Aviles P, Otero G, Faircloth G, Mateos MV, Richardson PG, Mollinedo F, San-Miguel JF, Anderson KC (2008) Aplidin, a marine organism-derived compound with potent antimyeloma activity in vitro and in vivo. 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Future Oncol 15(2):109\u2013120. https:\/\/doi.org\/10.2217\/fon-2018-0492","journal-title":"Future Oncol"}],"container-title":["Annals of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00277-026-06811-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00277-026-06811-w","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00277-026-06811-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T17:45:49Z","timestamp":1781631949000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00277-026-06811-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,17]]},"references-count":28,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1]]}},"alternative-id":["6811"],"URL":"https:\/\/doi.org\/10.1007\/s00277-026-06811-w","relation":{},"ISSN":["1432-0584"],"issn-type":[{"value":"1432-0584","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,17]]},"assertion":[{"value":"26 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 November 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 January 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"H.L received research support by AMGEN and Sanofi; and was speaker or participated in advisory boards for Janssen, BMS, Pfizer, Oncopetides, Menarini\/Stemline, and GSK. E.T. was in advisory boards for Amgen, AstraZeneca, EUSA Pharma, BMS, GSK, J&J, Menarini\/Stemline, Pfizer, Sanofi, and Takeda; received honoraria from Amgen, Antengene, AstraZeneca, EUSA Pharma, BMS, Forus, GSK, J&J, Menarini\/Stemline, Novartis, Pfizer, Sanofi, Swixx, and Takeda; received research funding from Amgen, GSK, J&J, Sanofi, and Takeda; and received travel expenses from Takeda. M.B. received honoraria from Sanofi, Celgene, Amgen, Janssen, Novartis, Bristol Myers Squibb, and AbbVie; served on advisory boards for Janssen and GlaxoSmithKline; and received research funding from Sanofi, Celgene, Amgen, Janssen, Novartis, Bristol Myers Squibb, and Mundipharma. S.M., C.K., J.J., A.N., S.E., J.G. and V.A. are employees of PharmaMar S.A. C.K., J.J., A.N., J.G. and V.A. are stock ownerships in PharmaMar S.A. R.D. and X.Y. are employees and stock ownerships of Medidata, a Dassault Syst\u00e8mes Company. M.V.M. received honoraria derived from lectures and participation in advisory boards from Johnson & Johnson, BMS, Amgen, GSK, AbbVie, Pfizer, Regeneron, Roche, Sanofi, Oncopeptides, and Kite.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"26"}}