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Blood, 1 January 2006, Vol. 107, No. 1, pp. 397-403.
Prepublished online as a Blood First Edition Paper on September 6, 2005September 13, 2005; DOI 10.1182/blood-2005-06-2573.
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Submitted June 30, 2005
Accepted August 22, 2005
Tandem autologous stem cell transplantation in high-risk de novo multiple myeloma: final results of the prospective and randomized IFM 99-04 protocol
Philippe Moreau*, Cyrille Hullin, Frederic Garban, Ibrahim Yakoub-Agha, Lotfi Benboubker, Michel Attal, Gerald Marit, Jean-Gabriel Fuzibet, Chantal Doyen, Laurent Voillat, Christian Berthou, Nicolas Ketterer, Philippe Casassus, Mathieu Monconduit, Mauricette Michallet, Albert Najman, Jean-Jacques Sotto, Regis Bataille, and Jean-Luc Harousseau
University Hospital, Nantes, France
University Hospital, Nancy, France
University Hospital, Grenoble, France
University Hospital, Lille, France
University Hospital, Tours, France
University Hospital, Toulouse, France
University Hospital, Bordeaux, France
University Hospital, Nice, France
University Hospital, Brussels, Belgium
University Hospital, Besancon, France
University Hospital, Brest, France
University Hospital, Lausanne, Switzerland
University Hospital, Paris, France
University Hospital, Rouen, France
University Hospital, Lyon, France
University Hospital, Paris Saint-Antoine, France
* Corresponding author; email: philippe.moreau{at}chu-nantes.fr.
The combination of high level of beta-2-microglobulin ( 2m) and chromosome 13 deletion allows to identify a high-risk subgroup of patients with de novo multiple myeloma (MM). In this population of patients, we have evaluated the impact of a murine anti-IL6 monoclonal antibody (BE-8) as part of the second conditioning regimen in a multicenter prospective randomized trial of tandem autologous stem cell transplantation (ASCT). The first ASCT was prepared by melphalan 200 mg/m2, and the second one by melphalan 220 mg/m2 plus dexamethasone with or without BE-8 infusion. Two hundred and nineteen patients were included in this trial and 166 were randomized, 85 without BE-8 (arm A) and 81 with BE-8 (arm B). The median overall survival (OS) and even-free survival (EFS) of the whole group of patients were 41 and 30 months, respectively. Response rates, OS and EFS were not different between the 2 arms of the trial: OS at 54 months 46% in arm A vs 51% in arm B (p = .90), median EFS 35 months in arm A vs 31 in arm B (p = .39). In high-risk patients the dose-intensity of melphalan 420 mg/m2 leaded to encouraging results, but the addition of anti-IL6 monoclonal antibody to the second conditioning regimen did not improve neither OS nor EFS.
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