Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02 - Archive ouverte HAL Access content directly
Journal Articles Blood Year : 2013

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

(1) , (2, 3) , (4) , (5) , (6) , (7) , (8) , , , , , (9) , (10) , (11) , , , , (12) , (1) , (13) , , (14) , (15) , (16) , (17) , , (18, 19) , (20, 21) ,
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
Xavier Leleu
  • Function : Author
Philippe Moreau
Marie Odile Petillon
  • Function : Author
Margaret Macro
  • Function : Author
Murielle Roussel
  • Function : Author
Brigitte Pegourie
  • Function : Author
Sabine Bréchignac
  • Function : Author
Nathalie Meuleman
  • Function : Author
Beatrice Thielemans
  • Function : Author
Laurent Garderet
Bruno Royer
  • Function : Author
Lotfi Benboubker
  • Function : Author
Denis Caillot
  • Function : Author
Jean Paul Fermand
  • Function : Author

Abstract

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).
Not file

Dates and versions

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

Identifiers

Cite

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⟩
327 View
0 Download

Altmetric

Share

Gmail Facebook Twitter LinkedIn More