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The \u2018Myeloma XI\u2019 trial, for newly diagnosed patients, aimed to evaluate whether the addition of the histone deacetylase inhibitor vorinostat to the lenalidomide maintenance backbone could improve outcomes further. Patients included in this analysis were randomised to maintenance therapy with lenalidomide alone (10\u2009mg\/day on days 1\u201321 of each 28\u2010day\u2009cycle), or in combination with vorinostat (300\u2009mg\/day on day 1\u20137 and 15\u201321 of each 28\u2010day\u2009cycle) with treatment continuing until unacceptable toxicity or progressive disease. There was no significant difference in median progression\u2010free survival between those receiving lenalidomide\u2010vorinostat or lenalidomide alone, 34 and 40\u2009months respectively (hazard ratio [HR] 1.18, 95% confidence interval [CI] 0.96\u20131.44, <jats:italic>p<\/jats:italic>\u00a0=\u00a00.109). There was also no significant difference in median OS, not estimable and 75\u2009months respectively (HR 0.99, 95% CI 0.76\u20131.29, <jats:italic>p<\/jats:italic>\u00a0=\u00a00.929). Subgroup analysis demonstrated no statistically significant heterogeneity in outcomes. Combination lenalidomide\u2010vorinostat appeared to be poorly tolerated with more dose modifications, fewer cycles of maintenance therapy delivered and higher rates of discontinuation due to toxicity than lenalidomide alone. The trial did not meet its primary end\u2010point, there was no benefit from the addition of vorinostat to lenalidomide maintenance.<\/jats:p>","DOI":"10.1111\/bjh.18600","type":"journal-article","created":{"date-parts":[[2022,12,21]],"date-time":"2022-12-21T09:16:29Z","timestamp":1671614189000},"page":"267-279","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["The addition of vorinostat to lenalidomide maintenance for patients with newly diagnosed multiple myeloma of all ages: results from \u2018Myeloma <scp>XI\u2019<\/scp>, a multicentre, open\u2010label, randomised, phase III trial"],"prefix":"10.1111","volume":"201","author":[{"given":"Matthew W.","family":"Jenner","sequence":"first","affiliation":[{"name":"University Hospital Southampton NHS Foundation Trust  Southampton 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Research University of Leeds  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Olivier","sequence":"additional","affiliation":[{"name":"Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research University of Leeds  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John R.","family":"Jones","sequence":"additional","affiliation":[{"name":"Eastbourne District General Hospital  Eastbourne UK"},{"name":"Brighton and Sussex Medical School University of Sussex  Sussex UK"},{"name":"Kings College Hospital NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamaraj","family":"Karunanithi","sequence":"additional","affiliation":[{"name":"University Hospitals of North Midlands NHS Trust  Stoke\u2010on\u2010Trent 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Immunotherapy University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3677-4804","authenticated-orcid":false,"given":"Martin F.","family":"Kaiser","sequence":"additional","affiliation":[{"name":"The Institute of Cancer Research  London UK"},{"name":"The Royal Marsden NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger G.","family":"Owen","sequence":"additional","affiliation":[{"name":"Haematological Malignancy Diagnostic Service (HMDS), Leeds Cancer Centre Leeds Teaching Hospitals Trust  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Gregory","sequence":"additional","affiliation":[{"name":"Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research University of Leeds  Leeds 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