Tandem autologous stem cell transplantation in high-risk de novo multiple myeloma: final results of the prospective and randomized IFM 99-04 protocol.

Details

Serval ID
serval:BIB_E5EB2D803BC3
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Tandem autologous stem cell transplantation in high-risk de novo multiple myeloma: final results of the prospective and randomized IFM 99-04 protocol.
Journal
Blood
Author(s)
Moreau P., Hullin C., Garban F., Yakoub-Agha I., Benboubker L., Attal M., Marit G., Fuzibet J.G., Doyen C., Voillat L., Berthou C., Ketterer N., Casassus P., Monconduit M., Michallet M., Najman A., Sotto J.J., Bataille R., Harousseau J.L.
Working group(s)
Intergroupe Francophone du Myélome group
ISSN
0006-4971 (Print)
ISSN-L
0006-4971
Publication state
Published
Issued date
2006
Volume
107
Number
1
Pages
397-403
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
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.
Keywords
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
Yes
Create date
28/04/2008 7:19
Last modification date
20/08/2019 16:09
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