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Blood, 1 October 2006, Vol. 108, No. 7, pp. 2165-2172. Prepublished online as a Blood First Edition Paper on June 13, 2006; DOI 10.1182/blood-2006-04-019778. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2006-04-019778v1 108/7/2165    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 patientINFORMation Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Mateos, M.-V. Articles by Miguel, J.-F. S. Search for Related Content PubMed PubMed Citation Articles by Mateos, M.-V. Articles by Miguel, J.-F. S. 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 plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study María-Victoria Mateos, José-M. Hernández, Miguel-T. Hernández, Norma-C. Gutiérrez, Luis Palomera, Marta Fuertes, Joaquín Díaz-Mediavilla, Juan-J. Lahuerta, Javier de la Rubia, María-José Terol, Ana Sureda, Joan Bargay, Paz Ribas, Felipe de Arriba, Adrian Alegre, Albert Oriol, Dolores Carrera, José García-Laraña, Ramón García-Sanz, Joan Bladé, Felipe Prósper, Gemma Mateo, Dixie-Lee Esseltine, Helgi van de Velde, and Jesús-F. San Miguel From the Hematology Division, Grupo Español de MM (GEM/PETHEMA), Spain; Millennium Pharmaceuticals, Cambridge, MA; and Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ. Standard first-line treatment for elderly multiple myeloma (MM) patients ineligible for stem cell transplantation is melphalan plus prednisone (MP). However, complete responses (CRs) are rare. Bortezomib is active in patients with relapsed MM, including elderly patients. This phase 1/2 trial in 60 untreated MM patients aged at least 65 years (half older than 75 years) was designed to determine dosing, safety, and efficacy of bortezomib plus MP (VMP). VMP response rate was 89%, including 32% immunofixation-negative CRs, of whom half of the IF– CR patients analyzed achieved immunophenotypic remission (no detectable plasma cells at 10–4 to 10–5 sensitivity). VMP appeared to overcome the poor prognosis conferred by retinoblastoma gene deletion and IgH translocations. Results compare favorably with our historical control data for MP—notably, response rate (89% versus 42%), event-free survival at 16 months (83% versus 51%), and survival at 16 months (90% versus 62%). Side effects were predictable and manageable; principal toxicities were hematologic, gastrointestinal, and peripheral neuropathy and were more evident during early cycles and in patients aged 75 years or more. In conclusion, in elderly patients ineligible for transplantation, the combination of bortezomib plus MP appears significantly superior to MP, producing very high CR rates, including immunophenotypic CRs, even in patients with poor prognostic features. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Find additional patient-related information at: Improving Outcomes for Older Myeloma Patients Related Article in Blood Online: Complete response in myeloma: a Trojan horse? Bart Barlogie and Guido Tricot Blood 2006 108: 2134. [Full Text] [PDF] This article has been cited by other articles: K. N. Utecht and J. Kolesar Bortezomib: A novel chemotherapeutic agent for hematologic malignancies Am. J. Health Syst. Pharm., July 1, 2008; 65(13): 1221 - 1231. [Abstract] [Full Text] [PDF] J. San-Miguel, J.-L. Harousseau, D. Joshua, and K. C. Anderson Individualizing Treatment of Patients With Myeloma in the Era of Novel Agents J. Clin. Oncol., June 1, 2008; 26(16): 2761 - 2766. [Abstract] [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] U. Bachmann, R. Schindler, M. Storr, A. Kahl, A. Joerres, and I. Sturm Combination of bortezomib-based chemotherapy and extracorporeal free light chain removal for treating cast nephropathy in multiple myeloma NDT Plus, April 1, 2008; 1(2): 106 - 108. [Abstract] [Full Text] [PDF] M.-V. Mateos, J. M. Hernandez, M. T. Hernandez, N. C. Gutierrez, L. Palomera, M. Fuertes, P. Garcia-Sanchez, J. J. Lahuerta, J. de la Rubia, M.-J. Terol, et al. Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: updated time-to-events results and prognostic factors for time to progression Haematologica, April 1, 2008; 93(4): 560 - 565. [Abstract] [Full Text] [PDF] R. Z. Orlowski and D. J. Kuhn Proteasome Inhibitors in Cancer Therapy: Lessons from the First Decade Clin. Cancer Res., March 15, 2008; 14(6): 1649 - 1657. [Abstract] [Full Text] [PDF] R. A. Kyle and S. V. Rajkumar Multiple myeloma Blood, March 15, 2008; 111(6): 2962 - 2972. [Abstract] [Full Text] [PDF] H. Brenner, A. Gondos, and D. Pulte Recent major improvement in long-term survival of younger patients with multiple myeloma Blood, March 1, 2008; 111(5): 2521 - 2526. [Abstract] [Full Text] [PDF] E. Colado, S. Alvarez-Fernandez, P. Maiso, J. Martin-Sanchez, M. B. Vidriales, M. Garayoa, E. M. Ocio, J. C. Montero, A. Pandiella, and J. F. San Miguel The effect of the proteasome inhibitor bortezomib on acute myeloid leukemia cells and drug resistance associated with the CD34+ immature phenotype Haematologica, January 1, 2008; 93(1): 57 - 66. [Abstract] [Full Text] [PDF] W. H.D. Hallett, E. Ames, M. Motarjemi, I. Barao, A. Shanker, D. L. Tamang, T. J. Sayers, D. Hudig, and W. J. Murphy Sensitization of Tumor Cells to NK Cell-Mediated Killing by Proteasome Inhibition J. Immunol., January 1, 2008; 180(1): 163 - 170. [Abstract] [Full Text] [PDF] J.-P. Fermand Initial Therapy for Multiple Myeloma: Role of Stem Cell Transplantation ASCO Educational Book, January 1, 2008; 2008(1): 375 - 379. [Abstract] [Full Text] [PDF] A. K. Stewart A Risk-adapted Approach to Myeloma Therapy ASCO Educational Book, January 1, 2008; 2008(1): 380 - 384. [Abstract] [Full Text] [PDF] C.-K. Min, M.-J. Lee, K.-S. Eom, S. Lee, J.-W. Lee, W.-S. Min, C.-C. Kim, M. Kim, J. Lim, Y. Kim, et al. 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[Abstract] [Full Text] [PDF] H. Ludwig, J. Drach, H. Graf, A. Lang, and J. G. Meran Reversal of acute renal failure by bortezomib-based chemotherapy in patients with multiple myeloma Haematologica, October 1, 2007; 92(10): 1411 - 1414. [Abstract] [Full Text] [PDF] Y. Murakawa, E. Sonoda, L. J. Barber, W. Zeng, K. Yokomori, H. Kimura, A. Niimi, A. Lehmann, G. Y. Zhao, H. Hochegger, et al. Inhibitors of the Proteasome Suppress Homologous DNA Recombination in Mammalian Cells Cancer Res., September 15, 2007; 67(18): 8536 - 8543. [Abstract] [Full Text] [PDF] F. E. Davies, P. Wu, M. Jenner, M. Srikanth, R. Saso, and G. J. Morgan The combination of cyclophosphamide, velcade and dexamethasone (CVD) induces high response rates with comparable toxicity to velcade alone (V) and velcade plus dexamethasone (VD) Haematologica, August 1, 2007; 92(8): 1149 - 1150. [Abstract] [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] M. Cavo, P. Tosi, E. Zamagni, C. Cellini, P. Tacchetti, F. Patriarca, F. Di Raimondo, E. Volpe, S. Ronconi, D. Cangini, et al. Prospective, Randomized Study of Single Compared With Double Autologous Stem-Cell Transplantation for Multiple Myeloma: Bologna 96 Clinical Study J. Clin. Oncol., June 10, 2007; 25(17): 2434 - 2441. [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] R. Fonseca Multiple myeloma and FISH (but no CHIPS) Blood, April 15, 2007; 109(8): 3132 - 3133. [Full Text] [PDF] A. Palumbo, M. T. Ambrosini, G. Benevolo, P. Pregno, N. Pescosta, V. Callea, C. Cangialosi, T. Caravita, F. Morabito, P. Musto, et al. Bortezomib, melphalan, prednisone, and thalidomide for relapsed multiple myeloma Blood, April 1, 2007; 109(7): 2767 - 2772. [Abstract] [Full Text] [PDF] J.-P. Armand, A. K. Burnett, J. Drach, J.-L. Harousseau, B. Lowenberg, and J. San Miguel The Emerging Role of Targeted Therapy for Hematologic Malignancies: Update on Bortezomib and Tipifarnib Oncologist, March 1, 2007; 12(3): 281 - 290. [Abstract] [Full Text] [PDF] R. Fonseca Strategies for Risk-Adapted Therapy in Myeloma Hematology, January 1, 2007; 2007(1): 304 - 310. [Abstract] [Full Text] [PDF] R. Z. Orlowski Initial Therapy of Multiple Myeloma Patients Who Are Not Candidates for Stem Cell Transplantation Hematology, January 1, 2006; 2006(1): 338 - 347. [Abstract] [Full Text] [PDF]

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