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Blood, 1 February 2002, Vol. 99, No. 3, pp. 731-735

PLENARY PAPER

Comparison of 200 mg/m2 melphalan and 8 Gy total body irradiation plus 140 mg/m2 melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the Intergroupe Francophone du Myélome 9502 randomized trial

Philippe Moreau, Thierry Facon, Michel Attal, Cyrille Hulin, Mauricette Michallet, Frédéric Maloisel, Jean-Jacques Sotto, François Guilhot, Gérald Marit, Chantal Doyen, Jérôme Jaubert, Jean-Gabriel Fuzibet, Sylvie François, Lotfi Benboubker, Matthieu Monconduit, Laurent Voillat, Margaret Macro, Christian Berthou, Véronique Dorvaux, Bernard Pignon, Bernard Rio, Thomas Matthes, Philippe Casassus, Denis Caillot, Norbert Najman, Bernard Grosbois, Régis Bataille, and Jean-Luc Harousseau for the Intergroupe Francophone du Myélome

From the Service d'Hématologie, Nantes, France; Service d'Hématologie, Lille, France; Service d'Hématologie, Toulouse, France; Service d'Hématologie, Nancy, France; Service d'Hématologie, Lyon-Sud, France; Service d'Hématologie, Strasbourg, France; Service d'Hématologie, Grenoble, France; Service d'Hématologie, Poitiers, France; Service d'Hématologie, Bordeaux, France; Service d'Hématologie, Bruxelles, Belgium; Service d'Hématologie, Saint-Etienne, France; Service d'Hématologie, Nice, France; Service d'Hématologie, Angers, France; Service d'Hématologie, Tours, France; Service d'Hématologie, Rouen, France; Service d'Hématologie, Besançon, France; Service d'Hématologie, Caen, France; Service d'Hématologie, Brest, France; Service d'Hématologie, Metz, France; Service d'Hématologie, Reims, France; Service d'Hématologie, Paris, France; Service d'Hématologie, Genève, Switzerland; Service d'Hématologie, Dijon, France; and Service d'Hématologie, Rennes, France.

High-dose therapy has become a common treatment for myeloma. The objective of this study (Intergroupe Francophone du Myélome [IFM] 9502 trial) was to compare in a prospective and randomized trial the 2 most widely used conditioning regimens before autologous stem cell transplantation in newly diagnosed symptomatic patients younger than 65 years old: 8 Gy total body irradiation plus 140 mg/m2 melphalan (arm A) versus 200 mg/m2 melphalan (arm B). A total of 282 evaluable patients were compared---140 in arm A and 142 in arm B. Baseline characteristics and disease response to 4 cycles of the VAD regimen performed before randomization and autologous stem cell transplantation were identical in the 2 treatment arms. In arm B, hematologic recovery was significantly faster for both the duration of neutropenia and thrombocytopenia, transfusion requirements were also significantly lower, and the median duration of hospitalization was significantly shorter. In arm A, the incidence of severe mucositis was significantly increased. The median duration of event-free survival was similar in both arms (21 vs 20.5 months, P = .6), but the 45-month survival was 65.8% in arm B versus 45.5% in arm A (P = .05). This difference might be attributed in part to better salvage regimens after relapse in arm B compared with arm A. We conclude that 200 mg/m2 melphalan is a less toxic and at least as effective conditioning regimen when compared with 8 Gy total body irradiation with 140 mg/m2 melphalan. This regimen should be considered as the standard of care before autologous stem cell transplantation in multiple myeloma.

© 2002 by The American Society of Hematology.
 

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Reduced duration of cytopenias following melphalan conditioning and autografting for multiple myeloma
Steven M. Devine, Balkrishna Jahagirdar, Koen van Besien, Philippe Moreau, and Jean-Luc Harousseau
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