Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study

摘要: Summary Background Thalidomide plus dexamethasone (TD) is a standard induction therapy for myeloma. We aimed to assess the efficacy and safety of addition bortezomib TD (VTD) versus alone as before, consolidation after, double autologous stem-cell transplantation in newly diagnosed multiple Methods Patients (aged 18–65 years) with previously untreated symptomatic myeloma were enrolled from 73 sites Italy between May, 2006, April, 2008, data collection continued until June 30, 2010. randomly allocated (1:1 ratio) by web-based system receive three 21-day cycles thalidomide (100 mg daily first 14 days 200 thereafter) (40 on 8 12 days, but not consecutively; total 320 per cycle), either or (1·3 mg/m 2 1, 4, 8, 11). The randomisation sequence was computer generated study coordinating team stratified disease stage. After transplantation, patients received two 35-day their assigned drug regimen, VTD TD, therapy. primary endpoint rate complete near response Analysis intention treat. treating physicians masked treatment allocation. This still underway recruiting participants, registered ClinicalTrials.gov, number NCT01134484, EudraCT, 2005-003723-39. Findings 480 (n=241 patients) (n=239). Six withdrew consent before start treatment, 236 238 included intention-to-treat analysis. therapy, achieved (31%, 95% CI 25·0–36·8) receiving VTD, 27 (11%, 7·3–15·4) (p Interpretation significantly improves response, represents new care who are eligible transplant. Funding Seragnoli Institute Haematology at University Bologna, Italy.