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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Richardson, P. G., Blood, E., Mitsiades, C. S., Jagannath, S., Zeldenrust, S. R., Alsina, M., Schlossman, R. L., Rajkumar, S. V., Desikan, K. R., Hideshima, T., Munshi, N. C., Kelly-Colson, K., Doss, D., McKenney, M. L., Gorelik, S., Warren, D., Freeman, A., Rich, R., Wu, A., Olesnyckyj, M., Wride, K., Dalton, W. S., Zeldis, J., Knight, R., Weller, E., Anderson, K. C.
(2006). A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood
108: 3458-3464
[Abstract][Full Text]
Attal, M., Harousseau, J.-L., Leyvraz, S., Doyen, C., Hulin, C., Benboubker, L., Agha, I. Y., Bourhis, J.-H., Garderet, L., Pegourie, B., Dumontet, C., Renaud, M., Voillat, L., Berthou, C., Marit, G., Monconduit, M., Caillot, D., Grobois, B., Avet-Loiseau, H., Moreau, P., Facon, T., for the Inter-Groupe Francophone du Myelome (IFM),
(2006). Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood
108: 3289-3294
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Sanchorawala, V.
(2006). Light-Chain (AL) Amyloidosis: Diagnosis and Treatment. CJASN
1: 1331-1341
[Abstract][Full Text]
Offidani, M., Corvatta, L., Piersantelli, M.-N., Visani, G., Alesiani, F., Brunori, M., Galieni, P., Catarini, M., Burattini, M., Centurioni, R., Ferranti, M., Rupoli, S., Scortechini, A. R., Giuliodori, L., Candela, M., Capelli, D., Montanari, M., Olivieri, A., Poloni, A., Polloni, C., Marconi, M., Leoni, P.
(2006). Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. Blood
108: 2159-2164
[Abstract][Full Text]
Mateos, M.-V., Hernandez, J.-M., Hernandez, M.-T., Gutierrez, N.-C., Palomera, L., Fuertes, M., Diaz-Mediavilla, J., Lahuerta, J.-J., de la Rubia, J., Terol, M.-J., Sureda, A., Bargay, J., Ribas, P., de Arriba, F., Alegre, A., Oriol, A., Carrera, D., Garcia-Larana, J., Garcia-Sanz, R., Blade, J., Prosper, F., Mateo, G., Esseltine, D.-L., van de Velde, H., Miguel, J.-F. S.
(2006). Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study. Blood
108: 2165-2172
[Abstract][Full Text]
Eom, K.-S., Min, C.-K., Lee, S., Kim, Y.-J., Kim, S.-Y., Kim, H.-J., Lee, J.-W., Min, W.-S., Kim, C.-C.
(2006). Efficacy of Up-Front Treatment with a Double Stem Cell Transplantation in Multiple Myeloma. Jpn J Clin Oncol
36: 432-438
[Abstract][Full Text]
Rizvi, M. A., Ghias, K., Davies, K. M., Ma, C., Weinberg, F., Munshi, H. G., Krett, N. L., Rosen, S. T.
(2006). Enzastaurin (LY317615), a protein kinase C{beta} inhibitor, inhibits the AKT pathway and induces apoptosis in multiple myeloma cell lines.. Molecular Cancer Therapeutics
5: 1783-1789
[Abstract][Full Text]
Hussein, M. A., Baz, R., Srkalovic, G., Agrawal, N., Suppiah, R., Hsi, E., Andresen, S., Karam, M. A., Reed, J., Faiman, B., Kelly, M., Walker, E.
(2006). Phase 2 Study of Pegylated Liposomal Doxorubicin, Vincristine, Decreased-Frequency Dexamethasone, and Thalidomide in Newly Diagnosed and Relapsed-Refractory Multiple Myeloma. Mayo Clin Proc.
81: 889-895
[Abstract][Full Text]
Condomines, M., Quittet, P., Lu, Z.-Y., Nadal, L., Latry, P., Lopez, E., Baudard, M., Requirand, G., Duperray, C., Schved, J.-F., Rossi, J.-F., Tarte, K., Klein, B.
(2006). Functional Regulatory T Cells Are Collected in Stem Cell Autografts by Mobilization with High-Dose Cyclophosphamide and Granulocyte Colony-Stimulating Factor.. J. Immunol.
176: 6631-6639
[Abstract][Full Text]
Trudel, S., Stewart, A. K., Rom, E., Wei, E., Li, Z. H., Kotzer, S., Chumakov, I., Singer, Y., Chang, H., Liang, S.-B., Yayon, A.
(2006). The inhibitory anti-FGFR3 antibody, PRO-001, is cytotoxic to t(4;14) multiple myeloma cells. Blood
107: 4039-4046
[Abstract][Full Text]
Garban, F., Attal, M., Michallet, M., Hulin, C., Bourhis, J. H., Yakoub-Agha, I., Lamy, T., Marit, G., Maloisel, F., Berthou, C., Dib, M., Caillot, D., dePrijck, B., Ketterer, N., Harousseau, J.-L., Sotto, J.-J., Moreau, P., for the Intergroupe Francophone du Myelome and the,
(2006). Prospective comparison of autologous stem cell transplantation followed by dose-reduced allograft (IFM99-03 trial) with tandem autologous stem cell transplantation (IFM99-04 trial) in high-risk de novo multiple myeloma. Blood
107: 3474-3480
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Copelan, E. A.
(2006). Hematopoietic stem-cell transplantation.. NEJM
354: 1813-1826
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Dingli, D., Nowakowski, G. S., Dispenzieri, A., Lacy, M. Q., Hayman, S. R., Rajkumar, S. V., Greipp, P. R., Litzow, M. R., Gastineau, D. A., Witzig, T. E., Gertz, M. A.
(2006). Flow cytometric detection of circulating myeloma cells before transplantation in patients with multiple myeloma: a simple risk stratification system. Blood
107: 3384-3388
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Dispenzieri, A., Lacy, M. Q., Katzmann, J. A., Rajkumar, S. V., Abraham, R. S., Hayman, S. R., Kumar, S. K., Clark, R., Kyle, R. A., Litzow, M. R., Inwards, D. J., Ansell, S. M., Micallef, I. M., Porrata, L. F., Elliott, M. A., Johnston, P. B., Greipp, P. R., Witzig, T. E., Zeldenrust, S. R., Russell, S. J., Gastineau, D., Gertz, M. A.
(2006). Absolute values of immunoglobulin free light chains are prognostic in patients with primary systemic amyloidosis undergoing peripheral blood stem cell transplantation. Blood
107: 3378-3383
[Abstract][Full Text]
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
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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
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Haubitz, M., Peest, D.
(2006). Myeloma - new approaches to combined nephrological-haematological management. Nephrol Dial Transplant
21: 582-590
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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
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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
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Orlowski, R. Z.
(2006). Initial Therapy of Multiple Myeloma Patients Who Are Not Candidates for Stem Cell Transplantation. ASH Education Book
2006: 338-347
[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]
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