Tandem autologous stem cell transplantation in high-risk de novo multiple myeloma: final results of the prospective and randomized IFM 99-04 protocol.
Détails
ID Serval
serval:BIB_E5EB2D803BC3
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Tandem autologous stem cell transplantation in high-risk de novo multiple myeloma: final results of the prospective and randomized IFM 99-04 protocol.
Périodique
Blood
Collaborateur⸱rice⸱s
Intergroupe Francophone du Myélome group
ISSN
0006-4971 (Print)
ISSN-L
0006-4971
Statut éditorial
Publié
Date de publication
2006
Volume
107
Numéro
1
Pages
397-403
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Résumé
The combination of high levels of beta2-microglobulin (beta2-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.
Mots-clé
Adult, Aged, Antibodies, Monoclonal/administration & dosage, Antibodies, Monoclonal/therapeutic use, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Chromosome Deletion, Chromosomes, Human, Pair 13, Dexamethasone/administration & dosage, Female, Hematopoietic Stem Cell Transplantation/methods, Hematopoietic Stem Cell Transplantation/mortality, Humans, Interleukin-6/immunology, Male, Melphalan/administration & dosage, Middle Aged, Multiple Myeloma/diagnosis, Multiple Myeloma/mortality, Risk Factors, Survival Analysis, Transplantation Conditioning/methods, Transplantation, Autologous, beta 2-Microglobulin/blood
Pubmed
Web of science
Open Access
Oui
Création de la notice
28/04/2008 8:19
Dernière modification de la notice
20/08/2019 17:09