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Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial
- Publication Year :
- 2008
-
Abstract
- The initial analysis of the oral combination melphalan, prednisone, and thalidomide (MPT) in newly diagnosed patients with myeloma showed significantly higher response rate and longer progression-free survival (PFS) than did the standard melphalan and prednisone (MP) combination and suggested a survival advantage. In this updated analysis, efficacy and safety end points were updated. Patients were randomly assigned to receive oral MPT or MP alone. Updated analysis was by intention to treat and included PFS, overall survival (OS), and survival after progression. After a median follow-up of 38.1 months, the median PFS was 21.8 months for MPT and 14.5 months for MP (P = .004). The median OS was 45.0 months for MPT and 47.6 months for MP (P = .79). In different patient subgroups, MPT improved PFS irrespective of age, serum concentrations of β2-microglobulin, or high International Staging System. Thalidomide or bortezomib administration as salvage regimens significantly improved survival after progression in the MP group (P = .002) but not in the MPT group (P = .34). These data confirm activity of MPT for PFS but failed to show any survival advantage. New agents in the management of relapsed disease could explain this finding. The study is registered at www.clinicaltrials.gov as #NCT00232934.
- Subjects :
- Melphalan
Oncology
medicine.medical_specialty
Immunology
BORTEZOMIB
Administration, Oral
PLUS THALIDOMIDE
Biochemistry
Disease-Free Survival
chemistry.chemical_compound
Prednisone
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Multiple myeloma
Aged
Aged, 80 and over
Intention-to-treat analysis
business.industry
Bortezomib
Surrogate endpoint
Age Factors
STAGING SYSTEM
DEXAMETHASONE
Cell Biology
Hematology
Middle Aged
medicine.disease
Nitrogen mustard
Thalidomide
Methotrexate
Treatment Outcome
chemistry
Cisplatin
Multiple Myeloma
business
Follow-Up Studies
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....36bb91b64578b4333d5f26b754174f3b