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Blood, 1 April 2007, Vol. 109, No. 7, pp. 2767-2772. Prepublished online as a Blood First Edition Paper on December 5, 2006; DOI 10.1182/blood-2006-08-042275. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2006-08-042275v1 109/7/2767    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map 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 Clinical Trials and Observations Neoplasia Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Bortezomib, melphalan, prednisone, and thalidomide for relapsed multiple myeloma Antonio Palumbo1, Maria Teresa Ambrosini1, Giulia Benevolo2, Patrizia Pregno2, Norbert Pescosta3, Vincenzo Callea4, Clotilde Cangialosi5, Tommaso Caravita6, Fortunato Morabito7, Pellegrino Musto8, Sara Bringhen1, Patrizia Falco1, Ilaria Avonto1, Federica Cavallo1, Mario Boccadoro1, for the Italian Multiple Myeloma Network, Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) 1 Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera (AO) S. Giovanni Battista, Turin, Italy; 2 Ematologia, Azienda Ospedaliera San Giovanni Battista, Turin, Italy; 3 Divisione di Ematologia, Ospedale Centrale, Bolzano, Italy; 4 Divisione di Ematologia, Ospedali Riuniti, Reggio Calabria, Italy; 5 Divisione di Ematologia e Trapianto di Midollo Osseo, Azienda Ospedaliera Cervello, Palermo, Italy; 6 Cattedra e Divisione di Ematologia, Università Tor Vergata, Ospedale San Eugenio, Rome, Italy; 7 Unità Ospedaliera Complessa (UOC) di Ematologia, Azienda Ospedaliera di Cosenza, Cosenza, Italy; 8 UOC di Ematologia e Trapianto di Cellule Staminali, Centro di Riferimento Oncologico Regionale (CROB), Rionero in Vulture, Italy In multiple myeloma (MM), the addition of thalidomide or bortezomib to the standard oral melphalan/prednisone combination significantly increased response rate and event-free survival. In this multicenter phase 1/2 trial, dosing, safety, and efficacy of the 4-drug combination, bortezomib, melphalan, prednisone, and thalidomide (VMPT) was determined. Bortezomib was administered at 3 dose levels (1.0 mg/m2, 1.3 mg/m2, or 1.6 mg/m2) on days 1, 4, 15, and 22; melphalan was given at a dose of 6 mg/m2 on days 1 through 5 and prednisone at 60 mg/m2 on days 1 through 5. Thalidomide was delivered at 50 mg on days 1 through 35. Each course was repeated every 35 days. The maximum tolerated dose of bortezomib was 1.3 mg/m2. Thirty patients with relapsed or refractory MM were enrolled; 20 patients (67%) achieved a partial response (PR) including 13 patients (43%) who achieved at least a very good PR. Among 14 patients who received VMPT as second-line treatment, the PR rate was 79% and the immunofixation-negative complete response rate 36%. The 1-year progression-free survival was 61%, and the 1-year survival from study entry was 84%. Grade 3 nonhematologic adverse events included infections (5 patients), fatigue (1), vasculitis (1), and peripheral neuropathy (2); no grade 4 toxicities were recorded. Initial results showed that VMPT is an effective salvage therapy with a very high proportion of responses. The incidence of neurotoxicities was unexpectedly low. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: Toward a new therapeutic backbone in myeloma Paul Richardson Blood 2007 109: 2672-2673. [Full Text] [PDF] This article has been cited by other articles: M. Zangari, J. Guerrero, F. Cavallo, H. K. Prasad, D. Esseltine, and L. Fink Hemostatic effects of bortezomib treatment in patients with relapsed or refractory multiple myeloma Haematologica, June 1, 2008; 93(6): 953 - 954. [Full Text] [PDF] A. Palumbo, F. Gay, S. Bringhen, A. Falcone, N. Pescosta, V. Callea, T. Caravita, F. Morabito, V. Magarotto, M. Ruggeri, et al. Bortezomib, doxorubicin and dexamethasone in advanced multiple myeloma Ann. Onc., June 1, 2008; 19(6): 1160 - 1165. [Abstract] [Full Text] [PDF] P. G. Richardson, P. Sonneveld, M. Schuster, D. Irwin, E. Stadtmauer, T. Facon, J.-L. Harousseau, D. Ben-Yehuda, S. Lonial, H. Goldschmidt, et al. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial Blood, November 15, 2007; 110(10): 3557 - 3560. [Abstract] [Full Text] [PDF] G. Cavaletti and E. Nobile-Orazio Bortezomib-induced peripheral neurotoxicity: still far from a painless gain Haematologica, October 1, 2007; 92(10): 1308 - 1310. [Full Text] [PDF] R. Manochakian, K. C. Miller, and A. A. Chanan-Khan Clinical Impact of Bortezomib in Frontline Regimens for Patients with Multiple Myeloma Oncologist, August 1, 2007; 12(8): 978 - 990. [Abstract] [Full Text] [PDF] P. G. Richardson, C. Mitsiades, R. Schlossman, N. Munshi, and K. Anderson New Drugs for Myeloma Oncologist, June 1, 2007; 12(6): 664 - 689. [Abstract] [Full Text] [PDF] Combination Therapy for Relapsed Multiple Myeloma Patients Journal Watch Oncology and Hematology, April 13, 2007; 2007(413): 2 - 2. [Full Text] P. Richardson, C. Mitsiades, R. Schlossman, I. Ghobrial, T. Hideshima, D. Chauhan, N. Munshi, and K. Anderson The Treatment of Relapsed and Refractory Multiple Myeloma Hematology, January 1, 2007; 2007(1): 317 - 323. [Abstract] [Full Text] [PDF]

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