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Previous Volume 348:1875-1883 May 8, 2003 Number 19 Next

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ABSTRACT

Background High-dose therapy with supporting autologous stem-cell transplantation remains a controversial treatment for cancer. In multiple myeloma, first-line regimens incorporating high-dose therapy yield higher remission rates than do conventional-dose treatments, but evidence that this translates into improved survival is limited.

Methods In this multicenter study, the Medical Research Council Myeloma VII Trial, we randomly assigned 407 patients with previously untreated multiple myeloma who were younger than 65 years of age to receive either standard conventional-dose combination chemotherapy or high-dose therapy and an autologous stem-cell transplant.

Results Among the 401 patients who could be evaluated, the rates of complete response were higher in the intensive-therapy group than in the standard-therapy group (44 percent vs. 8 percent, P<0.001). The rates of partial response were similar (42 percent and 40 percent, respectively; P=0.72), and the rates of minimal response were lower in the intensive-therapy group than in the standard-therapy group (3 percent vs. 18 percent, P<0.001). Intention-to-treat analysis showed a higher rate of overall survival (P=0.04 by the log-rank test) and progression-free survival (P<0.001) in the intensive-therapy group than in the standard-therapy group. As compared with standard therapy, intensive treatment increased median survival by almost 1 year (54.1 months [95 percent confidence interval, 44.9 to 65.2] vs. 42.3 months [95 percent confidence interval, 33.1 to 51.6]). There was a trend toward a greater survival benefit in the group of patients with a poor prognosis, as defined by a high beta₂-microglobulin level (more than 8 mg per liter).

Conclusions High-dose therapy with autologous stem-cell rescue is an effective first-line treatment for patients with multiple myeloma who are younger than 65 years of age.

Source Information

From the Academic Unit of Haematology and Oncology, Cancer Research United Kingdom Clinical Centre and Leukaemia Research Fund Unit (J.A.C., G.J.M., F.E.D., R.G.O., P.J.S.), and the Northern and Yorkshire Clinical Trials and Research Unit, Academic Unit of Epidemiology and Health Services Research (S.E.B., K.H., J.B.), University of Leeds, Leeds, United Kingdom; and the Department of Immunology, University of Birmingham, Birmingham, United Kingdom (M.T.D.).

Drs. Child and Morgan contributed equally to the article.

Address reprint requests to Professor Child at the Department of Haematology, General Infirmary, Great George St., Leeds, West Yorkshire LS1 3EX, United Kingdom, or at tony.child{at}leedsth.nhs.uk.

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• Cavo, M., Zamagni, E., Tosi, P., Tacchetti, P., Cellini, C., Cangini, D., de Vivo, A., Testoni, N., Nicci, C., Terragna, C., Grafone, T., Perrone, G., Ceccolini, M., Tura, S., Baccarani, M., for the writing committee of the Bologna 2002 stud, (2005). Superiority of thalidomide and dexamethasone over vincristine-doxorubicindexamethasone (VAD) as primary therapy in preparation for autologous transplantation for multiple myeloma. Blood 106: 35-39 [Abstract] [Full Text]  
• Richardson, P. G., Sonneveld, P., Schuster, M. W., Irwin, D., Stadtmauer, E. A., Facon, T., Harousseau, J.-L., Ben-Yehuda, D., Lonial, S., Goldschmidt, H., Reece, D., San-Miguel, J. F., Blade, J., Boccadoro, M., Cavenagh, J., Dalton, W. S., Boral, A. L., Esseltine, D. L., Porter, J. B., Schenkein, D., Anderson, K. C., the Assessment of Proteasome Inhibition for Extend, (2005). Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma. NEJM 352: 2487-2498 [Abstract] [Full Text]  
• Cheung, M. C., Pantanowitz, L., Dezube, B. J. (2005). AIDS-Related Malignancies: Emerging Challenges in the Era of Highly Active Antiretroviral Therapy. The Oncologist 10: 412-426 [Abstract] [Full Text]  
• van Rhee, F., Szmania, S. M., Zhan, F., Gupta, S. K., Pomtree, M., Lin, P., Batchu, R. B., Moreno, A., Spagnoli, G., Shaughnessy, J., Tricot, G. (2005). NY-ESO-1 is highly expressed in poor-prognosis multiple myeloma and induces spontaneous humoral and cellular immune responses. Blood 105: 3939-3944 [Abstract] [Full Text]  
• Raab, M. S., Cremer, F. W., Breitkreutz, I. N., Gerull, S., Luft, T., Benner, A., Goerner, M., Ho, A. D., Goldschmidt, H., Moos, M. (2005). Molecular monitoring of tumour load kinetics predicts disease progression after non-myeloablative allogeneic stem cell transplantation in multiple myeloma. Ann Oncol 16: 611-617 [Abstract] [Full Text]  
• Aviles, A., Nambo, M. J., Neri, N., Murillo, E., Castaneda, C., Cleto, S., Talavera, A., Gonzalez, M. (2005). Biological modifiers as cytoreductive therapy before stem cell transplant in previously untreated patientswith multiple myeloma. Ann Oncol 16: 219-221 [Abstract] [Full Text]  
• Zeifang, F., Zahlten-Hinguranage, A., Goldschmidt, H., Cremer, F., Bernd, L., Sabo, D. (2005). Long-term survival after surgical intervention for bone disease in multiple myeloma. Ann Oncol 16: 222-227 [Abstract] [Full Text]  
• Lin, B., Catley, L., LeBlanc, R., Mitsiades, C., Burger, R., Tai, Y.-T., Podar, K., Wartmann, M., Chauhan, D., Griffin, J. D., Anderson, K. C. (2005). Patupilone (epothilone B) inhibits growth and survival of multiple myeloma cells in vitro and in vivo. Blood 105: 350-357 [Abstract] [Full Text]  
• Chang, H., Qi, C., Yi, Q.-L., Reece, D., Stewart, A. K. (2005). p53 gene deletion detected by fluorescence in situ hybridization is an adverse prognostic factor for patients with multiple myeloma following autologous stem cell transplantation. Blood 105: 358-360 [Abstract] [Full Text]  
• Richardson, P. G., Kassarjian, A., Jing, W. (2004). Case 38-2004 - A 40-Year-Old Man with a Large Tumor of the Skull. NEJM 351: 2637-2645 [Full Text]  
• Stewart, A. K., Chen, C. I., Howson-Jan, K., White, D., Roy, J., Kovacs, M. J., Shustik, C., Sadura, A., Shepherd, L., Ding, K., Meyer, R. M., Belch, A. R. (2004). Results of a Multicenter Randomized Phase II Trial of Thalidomide and Prednisone Maintenance Therapy for Multiple Myeloma after Autologous Stem Cell Transplant. Clin. Cancer Res. 10: 8170-8176 [Abstract] [Full Text]  
• Gertz, M. A. (2004). Too old for transplantation: think again. Blood 104: 3000-3001 [Full Text]  
• Palumbo, A., Bringhen, S., Petrucci, M. T., Musto, P., Rossini, F., Nunzi, M., Lauta, V. M., Bergonzi, C., Barbui, A., Caravita, T., Capaldi, A., Pregno, P., Guglielmelli, T., Grasso, M., Callea, V., Bertola, A., Cavallo, F., Falco, P., Rus, C., Massaia, M., Mandelli, F., Carella, A. M., Pogliani, E., Liberati, A. M., Dammacco, F., Ciccone, G., Boccadoro, M. (2004). Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized controlled trial. Blood 104: 3052-3057 [Abstract] [Full Text]  
• Dispenzieri, A., Moreno-Aspitia, A., Suarez, G. A., Lacy, M. Q., Colon-Otero, G., Tefferi, A., Litzow, M. R., Roy, V., Hogan, W. J., Kyle, R. A., Gertz, M. A. (2004). Peripheral blood stem cell transplantation in 16 patients with POEMS syndrome, and a review of the literature. Blood 104: 3400-3407 [Abstract] [Full Text]  
• Goodman, H. J. B., Hawkins, P. N., Dispenzieri, A., Gertz, M. A., Kyle, R. A., Mehta, J. (2004). The role of PBSCT in treatment of AL amyloidosis is far from settled. Blood 104: 2991-2994 [Full Text]  
• Kyle, R. A., Rajkumar, S. V. (2004). Multiple Myeloma. NEJM 351: 1860-1873 [Full Text]  
• Straka, C., Oduncu, F., Hinke, A., Einsele, H., Drexler, E., Schnabel, B., Arseniev, L., Walther, J., Konig, A., Emmerich, B. (2004). Responsiveness to G-CSF before leukopenia predicts defense to infection in high-dose chemotherapy recipients. Blood 104: 1989-1994 [Abstract] [Full Text]  
• Kumar, S., Witzig, T. E., Timm, M., Haug, J., Wellik, L., Kimlinger, T. K., Greipp, P. R., Rajkumar, S. V. (2004). Bone marrow angiogenic ability and expression of angiogenic cytokines in myeloma: evidence favoring loss of marrow angiogenesis inhibitory activity with disease progression. Blood 104: 1159-1165 [Abstract] [Full Text]  
• Bross, P. F., Kane, R., Farrell, A. T., Abraham, S., Benson, K., Brower, M. E., Bradley, S., Gobburu, J. V., Goheer, A., Lee, S.-L., Leighton, J., Liang, C. Y., Lostritto, R. T., McGuinn, W. D., Morse, D. E., Rahman, A., Rosario, L. A., Verbois, S. L., Williams, G., Wang, Y.-C., Pazdur, R. (2004). Approval Summary for Bortezomib for Injection in the Treatment of Multiple Myeloma. Clin. Cancer Res. 10: 3954-3964 [Full Text]  
• Durie, B. G.M., Jacobson, J., Barlogie, B., Crowley, J. (2004). Magnitude of Response With Myeloma Frontline Therapy Does Not Predict Outcome: Importance of Time to Progression in Southwest Oncology Group Chemotherapy Trials. JCO 22: 1857-1863 [Abstract] [Full Text]  
• Morris, C., Iacobelli, S., Brand, R., Bjorkstrand, B., Drake, M., Niederwieser, D., Gahrton, G. (2004). Benefit and Timing of Second Transplantations in Multiple Myeloma: Clinical Findings and Methodological Limitations in a European Group for Blood and Marrow Transplantation Registry Study. JCO 22: 1674-1681 [Abstract] [Full Text]  
• Childs, R. W. (2004). Evolving trends in hematopoietic cell transplantation for solid tumors: tempering enthusiasm with clinical reality. Ann Oncol 15: 543-544 [Full Text]  
• Zervas, K., Dimopoulos, M. A., Hatzicharissi, E., Anagnostopoulos, A., Papaioannou, M., Mitsouli, Ch., Panagiotidis, P., Korantzis, J., Tzilianos, M., Maniatis, A. (2004). Primary treatment of multiple myeloma with thalidomide, vincristine, liposomal doxorubicin and dexamethasone (T-VAD doxil): a phase II multicenter study. Ann Oncol 15: 134-138 [Abstract] [Full Text]  
• Harousseau, J.-L., Shaughnessy, J. Jr., Richardson, P. (2004). Multiple Myeloma. ASH Education Book 2004: 237-256 [Abstract] [Full Text]  
• Barlogie, B., Shaughnessy, J., Tricot, G., Jacobson, J., Zangari, M., Anaissie, E., Walker, R., Crowley, J. (2004). Treatment of multiple myeloma. Blood 103: 20-32 [Abstract] [Full Text]  
• Attal, M., Harousseau, J.-L., Facon, T., Guilhot, F., Doyen, C., Fuzibet, J.-G., Monconduit, M., Hulin, C., Caillot, D., Bouabdallah, R., Voillat, L., Sotto, J.-J., Grosbois, B., Bataille, R., the InterGroupe Francophone du Myelome, (2003). Single versus Double Autologous Stem-Cell Transplantation for Multiple Myeloma. NEJM 349: 2495-2502 [Abstract] [Full Text]  
• Stadtmauer, E. A. (2003). Multiple Myeloma, 2004 -- One or Two Transplants?. NEJM 349: 2551-2553 [Full Text]  
• Dimopoulos, M. A., Anagnostopoulos, A., Weber, D. (2003). Treatment of Plasma Cell Dyscrasias With Thalidomide and Its Derivatives. JCO 21: 4444-4454 [Abstract] [Full Text]  
• Stanford, B. L, Zondor, S. D (2003). Bortezomib Treatment for Multiple Myeloma. The Annals of Pharmacotherapy 37: 1825-1830 [Abstract] [Full Text]  
• Blade, J., Vesole, D. H., Gertz, M. (2003). Transplantation for multiple myeloma: who, when, how often?. Blood 102: 3469-3477 [Full Text]  
• Vesole, D. H. (2003). "Full length, midi, or mini": a fashion statement for transplants in myeloma. Blood 102: 3081-3082 [Full Text]  
• Dasgupta, R. K., Adamson, P. J., Davies, F. E., Rollinson, S., Roddam, P. L., Ashcroft, A. J., Dring, A. M., Fenton, J. A. L., Child, J. A., Allan, J. M., Morgan, G. J. (2003). Polymorphic variation in GSTP1 modulates outcome following therapy for multiple myeloma. Blood 102: 2345-2350 [Abstract] [Full Text]  
• Singhal, S. (2003). Treatment of multiple myeloma. BMJ 327: 575-576 [Full Text]