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

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.

journal_name

Blood

journal_title

Blood

authors

Moreau P,Hullin C,Garban F,Yakoub-Agha I,Benboubker L,Attal M,Marit G,Fuzibet JG,Doyen C,Voillat L,Berthou C,Ketterer N,Casassus P,Monconduit M,Michallet M,Najman A,Sotto JJ,Bataille R,Harousseau JL,Intergroupe Fran

doi

10.1182/blood-2005-06-2573

subject

Has Abstract

pub_date

2006-01-01 00:00:00

pages

397-403

issue

1

eissn

0006-4971

issn

1528-0020

pii

2005-06-2573

journal_volume

107

pub_type

杂志文章,多中心研究,随机对照试验

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