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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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• Barlogie, B., Tricot, G., Rasmussen, E., Anaissie, E., van Rhee, F., Zangari, M., Fassas, A., Hollmig, K., Pineda-Roman, M., Shaughnessy, J., Epstein, J., Crowley, J. (2006). Total therapy 2 without thalidomide in comparison with total therapy 1: role of intensified induction and posttransplantation consolidation therapies. Blood 107: 2633-2638 [Abstract] [Full Text]  
• Barlogie, B., Tricot, G., Anaissie, E., Shaughnessy, J., Rasmussen, E., van Rhee, F., Fassas, A., Zangari, M., Hollmig, K., Pineda-Roman, M., Lee, C., Talamo, G., Thertulien, R., Kiwan, E., Krishna, S., Fox, M., Crowley, J. (2006). Thalidomide and Hematopoietic-Cell Transplantation for Multiple Myeloma. NEJM 354: 1021-1030 [Abstract] [Full Text]  
• Breitz, H. B., Wendt, R. E. III, Stabin, M. S., Shen, S., Erwin, W. D., Rajendran, J. G., Eary, J. F., Durack, L., Delpassand, E., Martin, W., Meredith, R. F. (2006). 166Ho-DOTMP Radiation-Absorbed Dose Estimation for Skeletal Targeted Radiotherapy. JNM 47: 534-542 [Abstract] [Full Text]  
• Haubitz, M., Peest, D. (2006). Myeloma - new approaches to combined nephrological-haematological management. Nephrol Dial Transplant 21: 582-590 [Full Text]  
• Berenson, J. R., Yang, H. H., Sadler, K., Jarutirasarn, S. G., Vescio, R. A., Mapes, R., Purner, M., Lee, S.-p., Wilson, J., Morrison, B., Adams, J., Schenkein, D., Swift, R. (2006). Phase I/II Trial Assessing Bortezomib and Melphalan Combination Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. JCO 24: 937-944 [Abstract] [Full Text]  
• Barlogie, B., Kyle, R. A., Anderson, K. C., Greipp, P. R., Lazarus, H. M., Hurd, D. D., McCoy, J., Dakhil, S. R., Lanier, K. S., Chapman, R. A., Cromer, J. N., Salmon, S. E., Durie, B., Crowley, J. C. (2006). Standard Chemotherapy Compared With High-Dose Chemoradiotherapy for Multiple Myeloma: Final Results of Phase III US Intergroup Trial S9321. JCO 24: 929-936 [Abstract] [Full Text]  
• Cavo, M., Terragna, C., Renzulli, M., Zamagni, E., Tosi, P., Testoni, N., Nicci, C., Cangini, D., Tacchetti, P., Grafone, T., Cellini, C., Ceccolini, M., Perrone, G., Martinelli, G., Baccarani, M., Guardigni, L. (2006). Poor Outcome With Front-Line Autologous Transplantation in t(4;14) Multiple Myeloma: Low Complete Remission Rate and Short Duration of Remission. JCO 24: e4-e5 [Full Text]  
• Rajkumar, S. V., Blood, E., Vesole, D., Fonseca, R., Greipp, P. R. (2006). Phase III Clinical Trial of Thalidomide Plus Dexamethasone Compared With Dexamethasone Alone in Newly Diagnosed Multiple Myeloma: A Clinical Trial Coordinated by the Eastern Cooperative Oncology Group. JCO 24: 431-436 [Abstract] [Full Text]  
• Richardson, P., Anderson, K. (2006). Thalidomide and Dexamethasone: A New Standard of Care for Initial Therapy in Multiple Myeloma. JCO 24: 334-336 [Full Text]  
• Donato, M. L., Feasel, A. M., Weber, D. M., Prieto, V. G., Giralt, S. A., Champlin, R. E., Duvic, M. (2006). Scleromyxedema: role of high-dose melphalan with autologous stem cell transplantation. Blood 107: 463-466 [Abstract] [Full Text]  
• Moreau, P., Hullin, C., Garban, F., Yakoub-Agha, I., Benboubker, L., Attal, M., Marit, G., Fuzibet, J.-G., Doyen, C., Voillat, L., Berthou, C., Ketterer, N., Casassus, P., Monconduit, M., Michallet, M., Najman, A., Sotto, J.-J., Bataille, R., Harousseau, J.-L., for the Intergroupe Francophone du Myelome group, (2006). Tandem autologous stem cell transplantation in high-risk de novo multiple myeloma: final results of the prospective and randomized IFM 99-04 protocol. Blood 107: 397-403 [Abstract] [Full Text]  
• Fermand, J.-P., Katsahian, S., Divine, M., Leblond, V., Dreyfus, F., Macro, M., Arnulf, B., Royer, B., Mariette, X., Pertuiset, E., Belanger, C., Janvier, M., Chevret, S., Brouet, J. C., Ravaud, P. (2005). High-Dose Therapy and Autologous Blood Stem-Cell Transplantation Compared With Conventional Treatment in Myeloma Patients Aged 55 to 65 Years: Long-Term Results of a Randomized Control Trial From the Group Myelome-Autogreffe. JCO 23: 9227-9233 [Abstract] [Full Text]  
• Augustson, B. M., Begum, G., Dunn, J. A., Barth, N. J., Davies, F., Morgan, G., Behrens, J., Smith, A., Child, J. A., Drayson, M. T. (2005). Early Mortality After Diagnosis of Multiple Myeloma: Analysis of Patients Entered Onto the United Kingdom Medical Research Council Trials Between 1980 and 2002--Medical Research Council Adult Leukaemia Working Party. JCO 23: 9219-9226 [Abstract] [Full Text]  
• Rajkumar, S. V., Hayman, S. R., Lacy, M. Q., Dispenzieri, A., Geyer, S. M., Kabat, B., Zeldenrust, S. R., Kumar, S., Greipp, P. R., Fonseca, R., Lust, J. A., Russell, S. J., Kyle, R. A., Witzig, T. E., Gertz, M. A. (2005). Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood 106: 4050-4053 [Abstract] [Full Text]  
• Trieu, Y., Trudel, S., Pond, G. R., Mikhael, J., Jaksic, W., Reece, D. E., Chen, C. I., Stewart, A. K. (2005). Weekly Cyclophosphamide and Alternate-Day Prednisone: An Effective, Convenient, and Well-Tolerated Oral Treatment for Relapsed Multiple Myeloma After Autologous Stem Cell Transplantation. Mayo Clin Proc. 80: 1578-1582 [Abstract]  
• Munshi, N. C., Anderson, K. C. (2005). To transplant or not to transplant?. Blood 106: 3687-3688 [Full Text]  
• Blade, J., Rosinol, L., Sureda, A., Ribera, J. M., Diaz-Mediavilla, J., Garcia-Larana, J., Mateos, M. V., Palomera, L., Fernandez-Calvo, J., Marti, J. M., Giraldo, P., Carbonell, F., Callis, M., Trujillo, J., Gardella, S., Moro, M. J., Barez, A., Soler, A., Font, L., Fontanillas, M., Miguel, J. S., for Programa para el Estudio de la Terapeutica en, (2005). High-dose therapy intensification compared with continued standard chemotherapy in multiple myeloma patients responding to the initial chemotherapy: long-term results from a prospective randomized trial from the Spanish cooperative group PETHEMA. Blood 106: 3755-3759 [Abstract] [Full Text]  
• Jalili, A., Ozaki, S., Hara, T., Shibata, H., Hashimoto, T., Abe, M., Nishioka, Y., Matsumoto, T. (2005). Induction of HM1.24 peptide-specific cytotoxic T lymphocytes by using peripheral-blood stem-cell harvests in patients with multiple myeloma. Blood 106: 3538-3545 [Abstract] [Full Text]  
• Batchu, R. B., Moreno, A. M., Szmania, S. M., Bennett, G., Spagnoli, G. C., Ponnazhagan, S., Barlogie, B., Tricot, G., van Rhee, F. (2005). Protein Transduction of Dendritic Cells for NY-ESO-1-Based Immunotherapy of Myeloma. Cancer Res. 65: 10041-10049 [Abstract] [Full Text]  
• Rajkumar, S. V., Kyle, R. A. (2005). Multiple Myeloma: Diagnosis and Treatment. Mayo Clin Proc. 80: 1371-1382 [Abstract]  
• Yasui, H., Hideshima, T., Hamasaki, M., Roccaro, A. M., Shiraishi, N., Kumar, S., Tassone, P., Ishitsuka, K., Raje, N., Tai, Y.-T., Podar, K., Chauhan, D., Leoni, L. M., Kanekal, S., Elliott, G., Munshi, N. C., Anderson, K. C. (2005). SDX-101, the R-enantiomer of etodolac, induces cytotoxicity, overcomes drug resistance, and enhances the activity of dexamethasone in multiple myeloma. Blood 106: 706-712 [Abstract] [Full Text]  
• 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]