Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02 - Centre de recherche en cancérologie Nantes-Angers Unité Mixte de Recherche 892 Inserm - 6299 CNRS Accéder directement au contenu
Article Dans Une Revue Blood Année : 2013

Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02

Xavier Leleu
  • Fonction : Auteur
Philippe Moreau
Marie Odile Petillon
  • Fonction : Auteur
Margaret Macro
  • Fonction : Auteur
Murielle Roussel
  • Fonction : Auteur
Brigitte Pegourie
  • Fonction : Auteur
Sabine Bréchignac
  • Fonction : Auteur
Nathalie Meuleman
  • Fonction : Auteur
Beatrice Thielemans
  • Fonction : Auteur
Laurent Garderet
Bruno Royer
  • Fonction : Auteur
Lotfi Benboubker
  • Fonction : Auteur
Denis Caillot
  • Fonction : Auteur
Jean Paul Fermand
  • Fonction : Auteur

Résumé

The combination of pomalidomide and dexamethasone can be safely administered to patients with multiple myeloma (MM) and has significant efficacy, although the optimal regimen remains to be determined. Patients with MM whose disease progressed after multiple lines of therapy have limited treatment options. We designed a multicenter, phase 2 randomized study assessing two different dose regimens of pomalidomide and dexamethasone in advanced MM. Treatment response was assessed centrally. Pomalidomide (4 mg) was given orally on days 1 to 21 (arm 21/28) or continuously (arm 28/28) over a 28-day cycle, plus dexamethasone given weekly. Eighty-four patients (43, arm 21/28 and 41, arm 28/28) were randomized. The median number of prior lines was 5. Overall response rate was 35% (arm 21/28) and 34% (arm 28/28), independent of the number of prior lines and level of refractoriness. Median duration of response, time to disease progression, and progression-free survival was 7.3, 5.4, and 4.6 months, respectively, which was similar across cohorts. At 23 months follow-up, median overall survival was 14.9 months, with 44% of the patients alive at 18 months. Toxicity consisted primarily of myelosuppression, which was manageable. The efficacy and safety data presented here, along with data from other phase 2 trials, suggest that pomalidomide 4 mg per day on days 1 to 21 of 28 with dexamethasone should be investigated in future trials. This trial is registered at ClinicalTrials.gov (No. NCT01053949).

Dates et versions

hal-01064417 , version 1 (16-09-2014)

Identifiants

Citer

Xavier Leleu, Michel Attal, Bertrand Arnulf, Philippe Moreau, Catherine Traulle, et al.. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02. Blood, 2013, 121 (11), pp.1968--1975. ⟨10.1182/blood-2012-09-452375⟩. ⟨hal-01064417⟩
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