title: Comparison of 200 mg/m(2) melphalan and 8 Gy total body irradiation plus 140 mg/m(2) 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.
abstract: 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/m(2) melphalan (arm A) versus 200 mg/m(2) 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/m(2) melphalan is a less toxic and at least as effective conditioning regimen when compared with 8 Gy total body irradiation with 140 mg/m(2) melphalan. This regimen should be considered as the standard of care before autologous stem cell transplantation in multiple myeloma.
authors.affiliation: Service d'Hématologie, University Hospital Hôtel-Dieu, Place Alexis Recordeau, 44093 Nantes cedex 01, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Michel
authors.initials: M
authors.lastname: Attal
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Frédéric
authors.initials: F
authors.lastname: Maloisel
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Sotto
authors.forename: François
authors.initials: F
authors.lastname: Guilhot
authors.forename: Gérald
authors.initials: G
authors.lastname: Marit
authors.forename: Chantal
authors.initials: C
authors.lastname: Doyen
authors.forename: Jérôme
authors.initials: J
authors.lastname: Jaubert
authors.forename: Jean-Gabriel
authors.initials: JG
authors.lastname: Fuzibet
authors.forename: Sylvie
authors.initials: S
authors.lastname: François
authors.forename: Lotfi
authors.initials: L
authors.lastname: Benboubker
authors.forename: Matthieu
authors.initials: M
authors.lastname: Monconduit
authors.forename: Laurent
authors.initials: L
authors.lastname: Voillat
authors.forename: Margaret
authors.initials: M
authors.lastname: Macro
authors.forename: Christian
authors.initials: C
authors.lastname: Berthou
authors.forename: Véronique
authors.initials: V
authors.lastname: Dorvaux
authors.forename: Bernard
authors.initials: B
authors.lastname: Pignon
authors.forename: Bernard
authors.initials: B
authors.lastname: Rio
authors.forename: Thomas
authors.initials: T
authors.lastname: Matthes
authors.forename: Philippe
authors.initials: P
authors.lastname: Casassus
authors.forename: Denis
authors.initials: D
authors.lastname: Caillot
authors.forename: Norbert
authors.initials: N
authors.lastname: Najman
authors.forename: Bernard
authors.initials: B
authors.lastname: Grosbois
authors.forename: Régis
authors.initials: R
authors.lastname: Bataille
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Harousseau
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000633:toxicity; D003131:Combined Modality Therapy / Q000379:methods; D005260:Female; D006085:Graft Survival; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods / Q000401:mortality / Q000592:standards; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000633:toxicity; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D012074:Remission Induction; D016019:Survival Analysis; D019172:Transplantation Conditioning / Q000379:methods; D014182:Transplantation, Autologous / Q000379:methods / Q000401:mortality / Q000592:standards; D016896:Treatment Outcome; D014916:Whole-Body Irradiation
chemical_list: D018906:Antineoplastic Agents, Alkylating; D008558:Melphalan