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Bortezomib plus Melphalan and Prednisone for Initial Treatment of Multiple Myeloma
- Source :
- Digital.CSIC. Repositorio Institucional del CSIC, instname
- Publication Year :
- 2008
- Publisher :
- Massachusetts Medical Society, 2008.
-
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.<br />[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<br />Supported by Johnson and Johnson Pharmaceutical Research and Development and Millennium Pharmaceuticals.
- 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
Subjects
Details
- ISSN :
- 15334406 and 00284793
- Volume :
- 359
- Database :
- OpenAIRE
- Journal :
- New England Journal of Medicine
- Accession number :
- edsair.doi.dedup.....53d79a57f22c587089a03af27a01e854