Background The median survival of patients with myeloma afterconventional chemotherapy is three years or less. Promisingresults have been reported with high-dose therapy supportedby autologous bone marrow transplantation. We conducted a randomizedstudy comparing conventional chemotherapy and high-dose therapy.
Methods Two hundred previously untreated patients under theage of 65 years who had myeloma were randomly assigned at thetime of diagnosis to receive either conventional chemotherapyor high-dose therapy and autologous bone marrow transplantation.
Results The response rate among the patients who received high-dosetherapy was 81 percent (including complete responses in 22 percentand very good partial responses in 16 percent), whereas it was57 percent (complete responses in 5 percent and very good partialresponses in 9 percent) in the group treated with conventionalchemotherapy (P<0.001). The probability of event-free survivalfor five years was 28 percent in the high-dose group and 10percent in the conventional-dose group (P = 0.01); the overallestimated rate of survival for five years was 52 percent inthe high-dose group and 12 percent in the conventional-dosegroup (P = 0.03). Treatment-related mortality was similar inthe two groups.
Conclusions High-dose therapy combined with transplantationimproves the response rate, event-free survival, and overallsurvival in patients with myeloma.
Source Information
From the Departments of Hematology and Biostatistics, Hôpital Purpan, Toulouse (M.A., C.P.); Hôtel Dieu, Nantes (J.-L.H., R.B.); Institut Paoli Calmettes, Marseilles (A.-M.S.); Hôpital Albert Michallon, Grenoble (J.-J.S.); Hôpital de Cimiez, Nice (J.-G.F.); Hôpital Lapeyronie, Montpellier (J.-F.R.); Hôpital Avicenne, Bobigny (P.C.); Hôpital de la Roche sur Yon, la Roche sur Yon (H.M.); Hôpital C. Huriez, Lille (T.F.); and the Centre Hospitalier et Universitaire d'Angers, Angers (N.I.) — all in France.
Address reprint requests to Dr. Attal at the Service d'Hématologie, Hôpital Purpan, Place du Docteur-Baylac, 31059 Toulouse, France.
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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]
Goodyear, O., Piper, K., Khan, N., Starczynski, J., Mahendra, P., Pratt, G., Moss, P.
(2005). CD8+T cells specific for cancer germline gene antigens are found in many patients with multiple myeloma, and their frequency correlates with disease burden. Blood
106: 4217-4224
[Abstract][Full Text]
Gribben, J. G., Zahrieh, D., Stephans, K., Bartlett-Pandite, L., Alyea, E. P., Fisher, D. C., Freedman, A. S., Mauch, P., Schlossman, R., Sequist, L. V., Soiffer, R. J., Marshall, B., Neuberg, D., Ritz, J., Nadler, L. M.
(2005). Autologous and allogeneic stem cell transplantations for poor-risk chronic lymphocytic leukemia. Blood
106: 4389-4396
[Abstract][Full Text]
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]
Richardson, P. G. G., Barlogie, B., Berenson, J., Singhal, S., Jagannath, S., Irwin, D., Rajkumar, S. V., Hideshima, T., Xiao, H., Esseltine, D., Schenkein, D., Anderson, K. C., for the SUMMIT Investigators,
(2005). Clinical factors predictive of outcome with bortezomib in patients with relapsed, refractory multiple myeloma. Blood
106: 2977-2981
[Abstract][Full Text]
Geffroy-Luseau, A., Moreau-Aubry, A., Bataille, R., Pellat-Deceunynck, C.
(2005). Allogeneic T lymphocytes as a source of peptide-dependent T cells specific for myeloma cells. Int Immunol
17: 1193-1200
[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]
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]
Abrahamsen, B., Andersen, I., Christensen, S. S, Skov Madsen, J., Brixen, K.
(2005). Utility of testing for monoclonal bands in serum of patients with suspected osteoporosis: retrospective, cross sectional study. BMJ
330: 818-
[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]
Trudel, S., Li, Z. H., Wei, E., Wiesmann, M., Chang, H., Chen, C., Reece, D., Heise, C., Stewart, A. K.
(2005). CHIR-258, a novel, multitargeted tyrosine kinase inhibitor for the potential treatment of t(4;14) multiple myeloma. Blood
105: 2941-2948
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Bae, J., Martinson, J. A., Klingemann, H. G.
(2005). Identification of CD19 and CD20 Peptides for Induction of Antigen-Specific CTLs against B-Cell Malignancies. Clin. Cancer Res.
11: 1629-1638
[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]
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]
Krett, N. L., Davies, K. M., Ayres, M., Ma, C., Nabhan, C., Gandhi, V., Rosen, S. T.
(2004). 8-Amino-adenosine is a potential therapeutic agent for multiple myeloma. Molecular Cancer Therapeutics
3: 1411-1420
[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
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Kyle, R. A., Rajkumar, S. V.
(2004). Multiple Myeloma. NEJM
351: 1860-1873
[Full Text]
Ballen, K. K., Becker, P. S., Yeap, B. Y., Matthews, B., Henry, D. H., Ford, P. A.
(2004). Autologous Stem-Cell Transplantation Can Be Performed Safely Without the Use of Blood-Product Support. JCO
22: 4087-4094
[Abstract][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]
Andre, F., Slimane, K., Bachelot, T., Dunant, A., Namer, M., Barrelier, A., Kabbaj, O., Spano, J. P., Marsiglia, H., Rouzier, R., Delaloge, S., Spielmann, M.
(2004). Breast Cancer With Synchronous Metastases: Trends in Survival During a 14-Year Period. JCO
22: 3302-3308
[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]
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