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Blood, 15 February 2006, Vol. 107, No. 4, pp. 1292-1298.
Prepublished online as a Blood First Edition Paper on September 20, 2005; DOI 10.1182/blood-2005-04-1588.


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Submitted April 19, 2005
Accepted July 13, 2005

Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy

Thierry Facon*, Jean-Yves Mary, Brigitte Pegourie, Michel Attal, Marc Renaud, Alain Sadoun, Laurent Voillat, Veronique Dorvaux, Cyrille Hulin, Gerard Lepeu, Jean-Luc Harousseau, Jean-Paul Eschard, Augustin Ferrant, Michel Blanc, Frederic Maloisel, Hubert Orfeuvre, Jean-Francois Rossi, Isabelle Azais, Mathieu Monconduit, Philippe Collet, Bruno Anglaret, Ibrahim Yakoub-Agha, Marc Wetterwald, Houchingue Eghbali, Marie-Christine Vekemans, Herve Maisonneuve, Jacques Troncy, Bernard Grosbois, Chantal Doyen, Antoine Thyss, Jerome Jaubert, Philippe Casassus, and Regis Bataille

Service d'Hematologie, CHU, Lille, France
Departemente de Biostatistique et Informatique Medicale, INSERM Erm0321,Hopital Saint-Louis,Universite Paris VII, Paris, France
Service d'Hematologie, CHU, Grenoble, France
Service d'Hematologie, CHU, Toulouse, France
Hematologie et Rhumatologie, CHU, Poitiers, France
CHU, Besancon, France
CH, Metz, France
CHU, Nancy, France
CH, Avignon, France
CHU, Nantes, France
Service d'Rhumatologie, CHU, Reims, France
Service d'Hematologie, UCL, Brussels, Belgium
Service d'Hematologie, CH, Chambery, France
CHU, Strasbourg, France
CH, Bourg-en-Bresse, France
CHU, Montpellier, France
Service d'Hematologie, Centre Henri Becquerel, Rouen, France
Service de Rhumatologie, CHU, Saint-Etienne, France
Service d'Hematologie, CH, Valence, France
CH, Saint-Brieuc, France
CH, Dunkerque, France
Service d'Hematologie, Institut Bergonie, Bordeaux, France
Service de Medecine, CH, La Roche/Yon, France
Service d'Hematologie, Hopital Edouard Herriot, Lyon, France
Service de Medecine Interne, CHU, Rennes, France
Service d'Hematologie, UCL, Yvoir, Belgium
Service d'Hematologie, Centre Lacassagne, Nice, France
CHU, Bobigny, France

* Corresponding author; email: t-facon{at}chru-lille.fr.

Dexamethasone alone increases life expectancy in patients with relapsed multiple myeloma (MM) ; however no large randomized study has compared dexamethasone and dexamethasone-based regimens with standard melphalan-prednisone in newly diagnosed MM patients, ineligible for high-dose therapy. In the IFM 95-01 trial, 488 patients, aged 65 to 75 years, were randomized between four regimens of treatment: melphalan-prednisone, dexamethasone alone, melphalan-dexamethasone and dexamethasone-interferon alpha. Response rates at 6 (except for complete response) were significantly higher among patients receiving melphalan-dexamethasone and progression-free survival was significantly better among patients receiving melphalan (P < .001, for both comparisons), but there was no difference in overall survival between the 4 treatment groups. Moreover, the morbidity associated with dexamethasone-based regimens was significantly higher than with melphalan-prednisone, especially for severe pyogenic infections in the melphalan-dexamethasone arm, and hemorrhage, severe diabetes, gastro intestinal and psychiatric complications in the dexamethasone arms. Overall, these results indicated that dexamethasone should not be routinely recommended as first-line treatment in elderly patients with MM. In the context of the IFM 95-01 trial, the standard melphalan-prednisone remained the best treatment choice, when efficacy and patient comfort were both considered. These results might be useful in the context of future combinations with innovative drugs.


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