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Four hundred patients were randomly assigned to receive either 100 or 400\u2003mg\/day of thalidomide. Dexamethasone treatment was added in both arms for patients with stable disease or treatment failure at 12\u2003weeks. The primary endpoint was 1\u2010year overall survival (OS). Thalidomide 100\u2003mg\/day was better tolerated than 400\u2003mg\/day with less high\u2010grade somnolence, constipation, nausea\/vomiting and peripheral neuropathy (<jats:italic>P\u2003<\/jats:italic>&lt;<jats:italic>\u2003<\/jats:italic>0.001, <jats:italic>P\u2003<\/jats:italic>=<jats:italic>\u2003<\/jats:italic>0.007, <jats:italic>P\u2003<\/jats:italic>=<jats:italic>\u2003<\/jats:italic>0.03 and <jats:italic>P\u2003<\/jats:italic>=<jats:italic>\u2003<\/jats:italic>0.007, respectively). In the per\u2010protocol population (PP), the estimated 1\u2010year OS rates were of 74.5% (<jats:italic>n<\/jats:italic>\u2003=\u2003149) and 67.3% (<jats:italic>n<\/jats:italic>\u2003=\u2003156) in the 400 and 100 groups, respectively. The upper limit of the difference between these rates was of 15.6% higher than the non\u2010inferiority acceptable limit of 12.75%, and the hypothesis of non\u2010inferiority of 100 could not be established (<jats:italic>P<\/jats:italic>\u2003=\u20030.14). On the other hand, when intent\u2010to\u2010treat (ITT) population was analysed, the non\u2010inferiority was demonstrated because the 1\u2010year OS rates were of 72.8% (<jats:italic>n<\/jats:italic>\u2003=\u2003195) and 68.8% (<jats:italic>n<\/jats:italic>\u2003=\u2003205) in the same groups, leading to an upper limit of the difference of 11.49% lower than the non\u2010inferiority acceptable limit. In addition, in patients alive 12\u2003weeks postrandomisation and those who received thalidomide plus dexamethasone, there were no significant differences in response rates, time to progression, progression\u2010free survival and OS between the two groups. Collectively, low\u2010dose thalidomide 100\u2003mg\/day has significant activity in advanced myeloma with an improved safety profile and can be a good salvage therapy in combination with dexamethasone.<\/jats:p>","DOI":"10.1111\/j.1600-0609.2011.01729.x","type":"journal-article","created":{"date-parts":[[2011,10,25]],"date-time":"2011-10-25T03:26:04Z","timestamp":1319513164000},"page":"249-259","source":"Crossref","is-referenced-by-count":17,"title":["Low\u2010dose vs. high\u2010dose thalidomide for advanced multiple myeloma: a prospective trial from the Intergroupe Francophone du 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