{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T18:16:25Z","timestamp":1787508985980,"version":"build-2736575974"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T00:00:00Z","timestamp":1764028800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T00:00:00Z","timestamp":1764028800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Alma Mater Studiorum - Universit\u00e0 di Bologna"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Exp Med"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Upfront lenalidomide in newly diagnosed multiple myeloma has become the gold standard. Nonetheless, proper management of lenalidomide-refractory patients is challenging. Daratumumab\u2013bortezomib\u2013dexamethasone (DaraVd) has been approved after\u2009\u2265\u20091 prior therapy, but data on upfront lenalidomide refractoriness are scarce. We run a retrospective study to assess the outcomes of 85 lenalidomide-refractory patients treated at first relapse with DaraVd in 10 Italian centers. Baseline characteristics were representative of a general population, despite inferior median age (57\u00a0years). Sixteen (27%) at diagnosis and 7 (29%) at relapse had high-risk cytogenetics (t(4;14) and\/or t(14;16) and\/or del17). Furthermore, one had del1p, one gain1q (3 copies) and one amp1q (\u2265\u20094 copies) at diagnosis; one gain1q and one amp1q at relapse. Overall response rate was 86% (61%\u2009\u2265\u2009VGPR). Median PFS and OS were 15 and 47\u00a0months, respectively (25-months median follow-up). Previous dose\/duration of lenalidomide did not influence PFS, favorably affected by the absence of amp1q (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.04), bone marrow plasma cells\u2009&lt;\u200960% (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.003), absence of extramedullary-disease (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.009), and\u2009\u2265\u2009VGPR (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001) or\u2009\u2265\u2009CR (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.012). In a multivariate model, response\u2009\u2265\u2009VGPR was confirmed to be independently associated to PFS (median: 26 vs. 7\u00a0months). At least one grade\u2009\u2265\u20092 adverse event (AE) occurred in 67 (85%) patients. Most common AEs were hematological (72%), infections\u00a0(30%, 8% grade-3,\u00a01% grade-5), pneumonia\u00a0(14%), and asthenia\u00a0(38%). Peripheral neuropathy rate was 58%\u00a0(8% grade-3). Toxicity-related bortezomib dose reduction occurred in 39\u00a0(49.4%) patients; 27 (44%) delayed Dara (1 median dose), mostly for infections. Three patients discontinued for toxicity.\u00a0Collectively, second-line DaraVd remains an alternative in lenalidomide-refractory patients, especially for those ineligible\u00a0for pomalidomide\/carfilzomib-based regimens, T-cell-redirecting therapies or other experimental drugs.\n                  <\/jats:p>","DOI":"10.1007\/s10238-025-01956-w","type":"journal-article","created":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T01:40:36Z","timestamp":1764034836000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A multicenter observational retrospective study of second-line treatment with daratumumab\u2013bortezomib\u2013dexamethasone (DaraVd) in multiple myeloma patients refractory to lenalidomide"],"prefix":"10.1007","volume":"26","author":[{"given":"I.","family":"Rizzello","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Sacchetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Barbato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Solli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Stefanoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Cani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Quaresima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Belotti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Sgherza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Gentile","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Zambello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Baril\u00e0","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Celli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Mele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Mancuso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Pantani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Tacchetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Talarico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Puppi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Manzato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Restuccia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Masci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Ghibellini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Bigi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Cavo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Zamagni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,25]]},"reference":[{"issue":"9","key":"1956_CR1","doi-asserted-by":"publisher","first-page":"1915","DOI":"10.1038\/leu.2016.380","volume":"31","author":"R Fonseca","year":"2017","unstructured":"Fonseca R, Abouzaid S, Bonafede M, et al. 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Characteristics and outcomes in patients with lenalidomide-refractory multiple myeloma treated with 1\u20133 prior lines of therapy: analysis of individual patient-level data from daratumumab clinical trials. Eur J Cancer. 2025;215:115157. https:\/\/doi.org\/10.1016\/j.ejca.2024.115157.","journal-title":"Eur J Cancer"},{"issue":"1","key":"1956_CR38","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1038\/s41408-024-01039-1","volume":"14","author":"U Goel","year":"2024","unstructured":"Goel U, Charalampous C, Kapoor P, et al. Outcomes of patients with multiple myeloma refractory to standard dose vs low dose lenalidomide. Blood Cancer J. 2024;14(1):55. https:\/\/doi.org\/10.1038\/s41408-024-01039-1.","journal-title":"Blood Cancer J"},{"issue":"1","key":"1956_CR39","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1007\/s00277-023-05443-8","volume":"103","author":"G Baril\u00e0","year":"2024","unstructured":"Baril\u00e0 G, Quaglia FM, Furlan A, et al. A real-life study of daratumumab-bortezomib-dexamethasone (D-VD) in lenalidomide exposed\/refractory multiple myeloma patients: a report from the Triveneto Myeloma Working Group. Ann Hematol. 2024;103(1):125\u201332. https:\/\/doi.org\/10.1007\/s00277-023-05443-8.","journal-title":"Ann Hematol"},{"issue":"29","key":"1956_CR40","doi-asserted-by":"publisher","first-page":"3279","DOI":"10.1200\/JCO.2017.72.6679","volume":"35","author":"PL McCarthy","year":"2017","unstructured":"McCarthy PL, Holstein SA, Petrucci MT, et al. Lenalidomide maintenance after autologous stem-cell transplantation in newly diagnosed multiple myeloma: a meta-analysis. JCO. 2017;35(29):3279\u201389. https:\/\/doi.org\/10.1200\/JCO.2017.72.6679.","journal-title":"JCO"}],"container-title":["Clinical and Experimental Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10238-025-01956-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10238-025-01956-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10238-025-01956-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T14:04:18Z","timestamp":1764079458000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10238-025-01956-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,25]]},"references-count":40,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["1956"],"URL":"https:\/\/doi.org\/10.1007\/s10238-025-01956-w","relation":{},"ISSN":["1591-9528"],"issn-type":[{"value":"1591-9528","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,25]]},"assertion":[{"value":"26 August 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 October 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 November 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"I. Rizzello has received honoraria from Amgen, GlaxoSmithKline and Sanofi and advisory role for GlaxoSmithKline and Menarini Stemline. A. Belotti has participated in Advisory Board for Amgen, GlaxoSmithKline, Pfizer, Sanofi, Menarini Stemline, Janssen. N. Sgherza has served in advisory boards for Sanofi. R. Zambello has served in advisory boards for Amgen, Janssen, Sanofi, GlaxoSmithKline, Oncopeptides, Menarini, Pfizer. G. Baril\u00e0 has served on Advisory Board for Menarini Stemline, Sanofi, Pfizer and has received honoraria from Sanofi, Johnson and Johnson, Menarini Stemline, Amgen, BMS. K. Mancuso has received honoraria from Celgene, Takeda, Amgen, Sanofi and Janssen. L. Pantani has received honoraria from GlaxoSmithKline, Pfizer and Sanofi. P. Tacchetti has received honoraria from Amgen, Bristol-Myers Squibb\/Celgene, Janssen, Takeda, AbbVie, Sanofi, GlaxoSmithKline, and Pfizer. M. Cavo has received honoraria and has served in a consulting\/advisory role for Amgen, AbbVie, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Menarini Stemline, Sanofi, and Karyopharm Therapeutics. E. Zamagni has received honoraria and has served in advisory role for Janssen, Bristol-Myers Squibb, Sanofi, Amgen, GlaxoSmithKline, Pfizer, Oncopeptides, Menarini Stemline. I. Sacchetti, S. Barbato, V. Solli, P. Stefanoni, L. Cani, M. Quaresima, M. Gentile, M. Celli, G. Mele, M. Talarico, M. Puppi, E. Manzato, R. Restuccia, S. Masci, S. Ghibellini, and F. Bigi declare no potential conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was approved by CE-AVEC and by local Ethics Committee in each participating center. The study was conducted in accordance with the International Conference on Harmonization Guidelines on Good Clinical Practice and the principles of the Declaration of Helsinki. All participants signed an informed consent form prior to their inclusion in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}}],"article-number":"43"}}