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Blood, 15 October 2008, Vol. 112, No. 8, pp. 3107-3114. Prepublished online as a Blood First Edition Paper on May 27, 2008; DOI 10.1182/blood-2008-04-149427. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2008-04-149427v1 112/8/3107    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Palumbo, A. Articles by Boccadoro, M. Search for Related Content PubMed PubMed Citation Articles by Palumbo, A. Articles by Boccadoro, M. Related Collections Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted April 1, 2008 Accepted May 2, 2008 Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized, controlled trial Antonio Palumbo*, Sara Bringhen, Anna M Liberati, Tommaso Caravita, Antonietta Falcone, Vincenzo Callea, Marco Montanaro, Roberto Ria, Antonio Capaldi, Renato Zambello, Giulia Benevolo, Daniele Derudas, Fausto Dore, Federica Cavallo, Francesca Gay, Patrizia Falco, Giovannino Ciccone, Pellegrino Musto, Michele Cavo, and Mario Boccadoro Divisione di Ematologia dell’Universita di Torino, Azienda Ospedaliera S Giovanni Battista, Torino, Italy Clinica Medica I, Policlinico Monteluce, Perugia, Italy Cattedra e Divisione di Ematologia, Universita Tor Vergata, Ospedale S Eugenio, Roma, Italy Unita Operativa di Ematologia Trapianto di Cellule Staminali, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy Divisione di Ematologia, Ospedali Riuniti, Calabria, Italy Unita Operativa Complessa di Ematologia, Ospedale Sant'Anna di Ronciglione, Ronciglione (VT), Italy Sezione Medicina Interna e Oncologia Clinica, Policlinico di Bari, Bari, Italy Divisione di Oncologia ed Ematologia, IRCCS, Candiolo, Italy Divisione di Ematologia e Immunologia Clinica Universitaria, Dipartimento Medicina Clinica e Sperimentale, Padova, Italy Ematologia, Azienda Ospedaliera San Giovanni Battista, Torino, Italy Unita Operativa di Ematologia, Ospedale "A. Businco", Cagliari, Italy Istituto di Ematologia, Universita di Sassari, Sassari, Italy Servizio di Epidemiologia dei Tumori dell’Universita di Torino, Azienda Ospedaliera S. Giovanni Battista e CPO Piemonte, Torino, Italy Ematologia e Trapianto Cellule Staminali IRCCS, Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Italy Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola, Bologna, Italy * Corresponding author; email: appalumbo{at}yahoo.com. Rationale: 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 endpoints were updated. Objectives: 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. Findings: 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 = .0004). 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 b2-microglobulin, or high International Staging System. Thalidomide or bortezomib administration as salvage regimens significantly improved survival after progression in the MP group (P = .0002) but not in the MPT group (P = .34). Conclusion: 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 ClinicalTrial.gov, number NCT00232934. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: Crossover confusion: MPT still best Brian G. M. Durie Blood 2008 112: 2998-2999. [Full Text] [PDF] This article has been cited by other articles: M. Cavo, F. Di Raimondo, E. Zamagni, F. Patriarca, P. Tacchetti, A. F. Casulli, S. Volpe, G. Perrone, A. Ledda, M. Ceccolini, et al. Short-Term Thalidomide Incorporated Into Double Autologous Stem-Cell Transplantation Improves Outcomes in Comparison With Double Autotransplantation for Multiple Myeloma J. Clin. Oncol., October 20, 2009; 27(30): 5001 - 5007. [Abstract] [Full Text] [PDF] J.-L. Harousseau, M. Attal, and H. Avet-Loiseau The role of complete response in multiple myeloma Blood, October 8, 2009; 114(15): 3139 - 3146. [Abstract] [Full Text] [PDF] C. Hulin, T. Facon, P. Rodon, B. Pegourie, L. Benboubker, C. Doyen, M. Dib, G. Guillerm, B. Salles, J.-P. Eschard, et al. Efficacy of Melphalan and Prednisone Plus Thalidomide in Patients Older Than 75 Years With Newly Diagnosed Multiple Myeloma: IFM 01/01 Trial J. Clin. Oncol., August 1, 2009; 27(22): 3664 - 3670. [Abstract] [Full Text] [PDF] J.-L. Harousseau, M. Dreyling, and On behalf of the ESMO Guidelines Working Group Multiple myeloma: ESMO Clinical Recommendations for diagnosis, treatment and follow-up Ann. Onc., May 1, 2009; 20(suppl_4): iv97 - iv99. [Full Text] [PDF] D. Reece, J.-L. Harousseau, and M. A. Gertz Nontransplant Therapy of Myeloma, High-dose Therapy for Myeloma, and a Personalized Care Plan for Treatment of Myeloma ASCO Educational Book, January 1, 2009; 2009(1): 502 - 509. [Abstract] [Full Text] [PDF] A. Dispenzieri Biology, treatment, and time Blood, October 15, 2008; 112(8): 2999 - 3000. [Full Text] [PDF]

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