1. Bortezomib plus Melphalan and Prednisone for Initial Treatment of Multiple Myeloma
- Author
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San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, Spicka I, Petrucci MT, Palumbo A, Samoilova OS, Dmoszynska A, Abdulkadyrov KM, Schots R, Jiang B, Mateos MV, Anderson KC, Esseltine DL, Liu K, Cakana A, van de Velde H, Richardson PG, VISTA Trial Investigators, Cavo M, Hematology, San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M,Spicka I, Petrucci MT, Palumbo A, Samoilova OS, Dmoszynska A, Abdulkadyrov KM,Schots R, Jiang B, Mateos MV, Anderson KC, Esseltine DL, Liu K, Cakana A, van de Velde H, Richardson PG, VISTA Trial Investigators [.., Cavo M, and ]
- Subjects
Male ,Melphalan ,Time Factors ,COMBINATION CHEMOTHERAPY ,ASSESSMENT SCHEDULE ,Gastroenterology ,Bortezomib ,PROGNOSTIC-FACTORS ,immune system diseases ,Prednisone ,hemic and lymphatic diseases ,Antineoplastic Combined Chemotherapy Protocols ,REFRACTORY MYELOMA ,Multiple myeloma ,Aged, 80 and over ,Hazard ratio ,General Medicine ,Middle Aged ,Boronic Acids ,Treatment Outcome ,Pyrazines ,Disease Progression ,Corticosteroid ,Female ,Multiple Myeloma ,PROGRESSION-FREE SURVIVAL ,medicine.drug ,medicine.medical_specialty ,medicine.drug_class ,ELDERLY UNTREATED PATIENTS ,Internal medicine ,medicine ,Humans ,cardiovascular diseases ,neoplasms ,Survival analysis ,Aged ,TRANSPLANTATION ,business.industry ,medicine.disease ,Survival Analysis ,RANDOMIZED-TRIAL ,Surgery ,PERIPHERAL NEUROPATHY ,APEX TRIAL ,Proteasome inhibitor ,business ,Follow-Up Studies - Abstract
12 páginas, 2 figuras, 3 tablas.-- Presented in part at the annual meeting of the American Society of Hematology, Atlanta, December 10, 2007.-- et al., [Background]: The standard treatment for patients with multiple myeloma who are not candidates for high-dose therapy is melphalan and prednisone. This phase 3 study compared the use of melphalan and prednisone with or without bortezomib in previously untreated patients with multiple myeloma who were ineligible for high-dose therapy. [Methods]: We randomly assigned 682 patients to receive nine 6-week cycles of melphalan (at a dose of 9 mg per square meter of body-surface area) and prednisone (at a dose of 60 mg per square meter) on days 1 to 4, either alone or with bortezomib (at a dose of 1.3 mg per square meter) on days 1, 4, 8, 11, 22, 25, 29, and 32 during cycles 1 to 4 and on days 1, 8, 22, and 29 during cycles 5 to 9. The primary end point was the time to disease progression. [Results]: The time to progression among patients receiving bortezomib plus melphalan-prednisone (bortezomib group) was 24.0 months, as compared with 16.6 months among those receiving melphalan-prednisone alone (control group) (hazard ratio for the bortezomib group, 0.48; P, Supported by Johnson and Johnson Pharmaceutical Research and Development and Millennium Pharmaceuticals.
- Published
- 2008