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.

Détails

ID Serval
serval:BIB_FEB844550F76
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
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.
Périodique
Journal of Clinical Oncology
Auteur(s)
Garderet L., Iacobelli S., Moreau P., Dib M., Lafon I., Niederwieser D., Masszi T., Fontan J., Michallet M., Gratwohl A., Milone G., Doyen C., Pegourie B., Hajek R., Casassus P., Kolb B., Chaleteix C., Hertenstein B., Onida F., Ludwig H., Ketterer N., Koenecke C., van Os M., Mohty M., Cakana A., Gorin N.C., de Witte T., Harousseau J.L., Morris C., Gahrton G.
ISSN
1527-7755 (Electronic)
ISSN-L
0732-183X
Statut éditorial
Publié
Date de publication
2012
Volume
30
Numéro
20
Pages
2475-2482
Langue
anglais
Notes
Publication types: Journal ArticlePublication Status: ppublish
Résumé
PURPOSE This prospective multicenter phase III study compared the efficacy and safety of a triple combination (bortezomib-thalidomide-dexamethasone [VTD]) versus a dual combination (thalidomide-dexamethasone [TD]) in patients with multiple myeloma (MM) progressing or relapsing after autologous stem-cell transplantation (ASCT). PATIENTS AND METHODS Overall, 269 patients were randomly assigned to receive bortezomib (1.3 mg/m(2) intravenous bolus) or no bortezomib for 1 year, in combination with thalidomide (200 mg per day orally) and dexamethasone (40 mg orally once a day on 4 days once every 3 weeks). Bortezomib was administered on days 1, 4, 8, and 11 with a 10-day rest period (day 12 to day 21) for eight cycles (6 months), and then on days 1, 8, 15, and 22 with a 20-day rest period (day 23 to day 42) for four cycles (6 months). Results Median time to progression (primary end point) was significantly longer with VTD than TD (19.5 v 13.8 months; hazard ratio, 0.59; 95% CI, 0.44 to 0.80; P = .001), the complete response plus near-complete response rate was higher (45% v 25%; P = .001), and the median duration of response was longer (17.2 v 13.4 months; P = .03). The 24-month survival rate was in favor of VTD (71% v 65%; P = .093). Grade 3 peripheral neuropathy was more frequent with VTD (29% v 12%; P = .001) as were the rates of grades 3 and 4 infection and thrombocytopenia. CONCLUSION VTD was more effective than TD in the treatment of patients with MM with progressive or relapsing disease post-ASCT but was associated with a higher incidence of grade 3 neurotoxicity.
Pubmed
Web of science
Création de la notice
02/08/2012 18:38
Dernière modification de la notice
20/08/2019 17:29
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