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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 13, 2005; DOI 10.1182/blood-2005-06-2573.
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TRANSPLANTATION
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,
Frédéric Garban,
Ibrahim Yakoub-Agha,
Lotfi Benboubker,
Michel Attal,
Gérald Marit,
Jean-Gabriel Fuzibet,
Chantal Doyen,
Laurent Voillat,
Christian Berthou,
Nicolas Ketterer,
Philippe Casassus,
Mathieu Monconduit,
Mauricette Michallet,
Albert Najman,
Jean-Jacques Sotto,
Régis Bataille,
Jean-Luc Harousseau, for the Intergroupe Francophone du Myélome group
From the 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, Besançon, France; University Hospital, Brest, France; University Hospital, Lausanne, Switzerland (for the Swiss Group for Clinical Cancer Research [SAKK]); University Hospital, Paris Bobigny, France; University Hospital, Rouen, France; University Hospital, Lyon, France; University Hospital, Paris Saint-Antoine, France.
The combination of high levels of  2-microglobulin (2-m) and chromosome 13 deletion allows identification of 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–interleukin 6 (anti–IL-6) monoclonal antibody (BE-8) as part of the second conditioning regimen in a multicenter prospective randomized trial of tandem autologous stem cell transplantation (ASCT). Conditioning for the first ASCT was accomplished with melphalan 200 mg/m2 and for the second one with melphalan 220 mg/m2 plus dexamethasone with or without BE-8 infusion. This trial included 219 patients, of whom 166 were randomized, 85 without BE-8 (arm A) and 81 with BE-8 (arm B). The median overall survival (OS) and event-free survival (EFS) times 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 was 46% in arm A and 51% in arm B (P = .90); median EFS was 35 months in arm A and 31 in arm B (P = .39). In high-risk patients the dose intensity of melphalan at 420 mg/m2 led to encouraging results, but the addition of anti–IL-6 monoclonal antibody to the second conditioning regimen did not improve either OS nor EFS.
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