Superiority of the Triple Combination of Bortezomib-Thalidomide-Dexamethasone Over the Dual Combination of Thalidomide-Dexamethasone in Patients With Multiple Myeloma Progressing or Relapsing After Autologous Transplantation: The MMVAR/IFM 2005-04 Randomized Phase III Trial From the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation

摘要: PURPOSE: This prospective multicenter phase III study compared the efficacy and safety of a triple combination (bortezomib-thalidomide-dexamethasone [VTD]) versus dual (thalidomide-dexamethasone [TD]) in patients with multiple myeloma (MM) progressing or relapsing after autologous stem-cell transplantation (ASCT). PATIENTS AND METHODS: Overall, 269 were randomly assigned to receive bortezomib (1.3 mg/m(2) intravenous bolus) no for 1 year, thalidomide (200 mg per day orally) dexamethasone (40 orally once on 4 days every 3 weeks). Bortezomib was administered 1, 4, 8, 11 10-day rest period (day 12 21) eight cycles (6 months), then 15, 22 20-day 23 42) four months). RESULTS: Median time progression (primary end point) significantly longer VTD than TD (19.5 v 13.8 months; hazard ratio, 0.59; 95% CI, 0.44 0.80; P = .001), complete response plus near-complete rate higher (45% 25%; median duration (17.2 13.4 .03). The 24-month survival favor (71% 65%; .093). Grade peripheral neuropathy more frequent (29% 12%; .001) as rates grades infection thrombocytopenia. CONCLUSION: effective treatment MM progressive disease post-ASCT but associated incidence grade neurotoxicity.