Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma

作者：Moreau Philippe; Avet Loiseau Herve; Facon Thierry; Attal Michel; Tiab Mourad; Hulin Cyrille; Doyen Chantal; Garderet Laurent; Randriamalala Edouard; Araujo Carla; Lepeu Gerard; Marit Gerald; Caillot Denis; Escoffre Martine; Lioure Bruno; Benboubker Lotfi; Pegourie Brigitte; Kolb Brigitte; Stoppa Anne Marie; Fuzibet Jean Gabriel; Decaux Olivier; Dib Mamoun; Berthou Christian; Chaleteix Carine; Sebban Catherine; Traulle Catherine; Fontan Jean; Wetterwald Marc

来源：Blood, 2011, 118(22): 5752-5758.

DOI：10.1182/blood-2011-05-355081

The Intergroupe Francophone du Myelome conducted a randomized trial to compare bortezomib-dexamethasone (VD) as induction before high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) to a combination consisting of reduced doses of bortezomib and thalidomide plus dexamethasone (vtD) in patients with multiple myeloma. Overall, a total of 199 patients were centrally randomly assigned to receive VD or vtD. After 4 cycles, the complete response (CR) rate was the same in both groups (13% in the vtD arm, 12% in the VD arm, P = .74). However, the CR plus very good partial response (VGPR) rate was significantly higher in the vtD arm (49% vs 36%, P = .05). After ASCT, the CR plus VGPR rate was significantly higher in the vtD arm (74% vs 58%, P = .02). The reduced doses of bortezomib and thalidomide translated into a reduced incidence of peripheral neuropathy (PN): grade >= 2 PN were reported in 34% in the VD arm versus 14% in the vtD arm (P = .001). vtD, including reduced doses of bortezomib and thalidomide, yields higher VGPR rates compared with VD and can be considered a new effective triplet combination before HDT/ASCT. This study was registered with www.clinicaltrials.gov as #NCT00910897 and EudraCT as #2007-005204-40. (Blood. 2011;118(22):5752-5758)

• 出版日期2011-11-24