{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:03:53Z","timestamp":1777543433005,"version":"3.51.4"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2012,3,30]],"date-time":"2012-03-30T00:00:00Z","timestamp":1333065600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2012,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Objectives:\u2002<\/jats:bold> Thalidomide and bortezomib have been frequently used for second\u2010line therapy in patients with myeloma relapsing after or refractory to initial melphalan\u2010based treatment, but no randomized trials have been published comparing these two treatment alternatives.<\/jats:p><jats:p><jats:bold>Methods:\u2002<\/jats:bold> Thalidomide\u2010 and bortezomib\u2010na\u00efve patients with melphalan refractory myeloma were randomly assigned to low\u2010dose thalidomide\u2003+\u2003dexamethasone (Thal\u2010Dex) or bortezomib\u2003+\u2003dexamethasone (Bort\u2010Dex). At progression on either therapy, the patients were offered crossover to the alternative drug combination. An estimated 300 patients would be needed for the trial to detect a 50% difference in median PFS between the treatment arms.<\/jats:p><jats:p><jats:bold>Results:\u2002<\/jats:bold> After inclusion of 131 patients, the trial was prematurely closed because of low accrual. Sixty\u2010seven patients were randomized to Thal\u2010Dex and 64 to Bort\u2010Dex. Progression\u2010free survival was similar (median, 9.0\u2003months for Thal\u2010Dex and 7.2 for Bort\u2010Dex). Response rate was similar (55% for Thal\u2010Dex and 63% for Bort\u2010Dex), but time to response was shorter (<jats:italic>P<\/jats:italic>\u2003&lt;\u20030.05) and the VGPR rate higher (<jats:italic>P<\/jats:italic>\u2003&lt;\u20030.01) for Bort\u2010Dex. Time\u2010to\u2010other treatment after crossover was similar (median, 13.2\u2003months for Thal\u2010Dex and 11.2\u2003months for Bort\u2010Dex), as was overall survival (22.8\u2003months for Thal\u2010Dex and 19.0 for Bort\u2010Dex). Venous thromboembolism was seen in seven patients and cerebrovascular events in four patients in the Thal\u2010Dex group. Severe neuropathy, reactivation of herpes virus infections, and mental depression were more frequently observed in the Bort\u2010Dex group. In the quality\u2010of\u2010life analysis, no difference was noted for physical function, pain, and global quality of life. Fatigue and sleep disturbances were significantly more prevalent in the Bort\u2010Dex group.<\/jats:p><jats:p><jats:bold>Conclusions:\u2002<\/jats:bold> Thalidomide (50\u2013100\u2003mg daily) in combination with dexamethasone seems to have an efficacy comparable with that of bortezomib and dexamethasone in melphalan refractory myeloma. However, the statistical strength of the results in this study is limited by the low number of included patients.<\/jats:p>","DOI":"10.1111\/j.1600-0609.2012.01775.x","type":"journal-article","created":{"date-parts":[[2012,3,8]],"date-time":"2012-03-08T17:34:29Z","timestamp":1331228069000},"page":"485-496","source":"Crossref","is-referenced-by-count":39,"title":["Thalidomide and dexamethasone vs. bortezomib and dexamethasone for melphalan refractory myeloma: a randomized study"],"prefix":"10.1111","volume":"88","author":[{"given":"Martin","family":"Hjorth","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00d8yvind","family":"Hjertner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lene 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