Background We conducted a randomized trial of the treatmentof multiple myeloma with high-dose chemotherapy followed byeither one or two successive autologous stem-cell transplantations.
Methods At the time of diagnosis, 399 previously untreated patientsunder the age of 60 years were randomly assigned to receivea single or double transplant.
Results A complete or a very good partial response was achievedby 42 percent of patients in the single-transplant group and50 percent of patients in the double-transplant group (P=0.10).The probability of surviving event-free for seven years afterthe diagnosis was 10 percent in the single-transplant groupand 20 percent in the double-transplant group (P=0.03). Theestimated overall seven-year survival rate was 21 percent inthe single-transplant group and 42 percent in the double-transplantgroup (P=0.01). Among patients who did not have a very goodpartial response within three months after one transplantation,the probability of surviving seven years was 11 percent in thesingle-transplant group and 43 percent in the double-transplantgroup (P<0.001). Four factors were significantly relatedto survival: base-line serum levels of beta2-microglobulin (P<0.01)and lactate dehydrogenase (P<0.01), age (P<0.05), andtreatment group (P<0.01).
Conclusions As compared with a single autologous stem-cell transplantationafter high-dose chemotherapy, double transplantation improvesoverall survival among patients with myeloma, especially thosewho do not have a very good partial response after undergoingone transplantation.
Source Information
From the Departments of Hematology and Biostatistics, Hôpital Purpan, Toulouse, France (M.A.); Hôtel Dieu, Nantes, France (J.-L.H., R. Bataille); Hôpital C. Huriez, Lille, France (T.F.); Centre Hospitalier la Mileterie, Poitiers, France (F.G.); Centre Universitaire Saint Luc, Brussells, Belgium (C.D.); Hôpital du Cimiez, Nice, France ( J.-G.F.); Centre Henri Becquerel, Rouen, France (M.M.); Centre Hospitalier Brabois, Nancy, France (C.H.); Centre Hospitalier Le Bocage, Dijon, France (D.C.); Institut Paoli Calmettes, Marseilles, France (R. Bouabdallah); Hôpital Jean Minjoz, Besançon, France (L.V.); Hôpital Albert Michallon, Grenoble, France (J.-J.S.); and Hôpital Sud, Rennes, France (B.G.).
Address reprint requests to Dr. Attal at the Service d'Hématologie, Hôpital Purpan, Place du Dr. Baylac, 31059 Toulouse, France, or at attal.m{at}chu-toulouse.fr.
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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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Cavo, M., Baccarani, M.
(2006). The Changing Landscape of Myeloma Therapy. NEJM
354: 1076-1078
[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]
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]
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
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Rajkumar, S. V., Kyle, R. A.
(2005). Multiple Myeloma: Diagnosis and Treatment. Mayo Clin Proc.
80: 1371-1382
[Abstract]
Saunders, G.
(2005). Overview of drug therapy for multiple myeloma. J Oncol Pharm Pract
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[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]
Hideshima, T., Bradner, J. E., Wong, J., Chauhan, D., Richardson, P., Schreiber, S. L., Anderson, K. C.
(2005). Small-molecule inhibition of proteasome and aggresome function induces synergistic antitumor activity in multiple myeloma. Proc. Natl. Acad. Sci. USA
102: 8567-8572
[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]
Reece, D. E.
(2005). An Update of the Management of Multiple Myeloma: The Changing Landscape. ASH Education Book
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[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
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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
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Kyle, R. A., Rajkumar, S. V.
(2004). Multiple Myeloma. NEJM
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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]
Stein, S. H.
(2004). Update in Oncology. ANN INTERN MED
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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.
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Murashige, N., Kishi, Y., Chng, W. J., Musto, P., Attal, M.
(2004). Tandem Bone Marrow Transplantation in Multiple Myeloma. NEJM
350: 1466-1467
[Full Text]
Harousseau, J.-L., Shaughnessy, J. Jr., Richardson, P.
(2004). Multiple Myeloma. ASH Education Book
2004: 237-256
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Stadtmauer, E. A.
(2003). Multiple Myeloma, 2004 -- One or Two Transplants?. NEJM
349: 2551-2553
[Full Text]
A correction has been published: N Engl J Med 2004;350(25):2628.
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