title: Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02.
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).
authors: Hôpital Huriez, CHRU, Lille, France. xavier.leleu@chru-lille.fr
authors: Xavier
authors: X
authors: Leleu
authors: Michel
authors: M
authors: Attal
authors: Bertrand
authors: B
authors: Arnulf
authors: Philippe
authors: P
authors: Moreau
authors: Catherine
authors: C
authors: Traulle
authors: Gerald
authors: G
authors: Marit
authors: Claire
authors: C
authors: Mathiot
authors: Marie Odile
authors: MO
authors: Petillon
authors: Margaret
authors: M
authors: Macro
authors: Murielle
authors: M
authors: Roussel
authors: Brigitte
authors: B
authors: Pegourie
authors: Brigitte
authors: B
authors: Kolb
authors: Anne Marie
authors: AM
authors: Stoppa
authors: Bernadette
authors: B
authors: Hennache
authors: Sabine
authors: S
authors: Bréchignac
authors: Nathalie
authors: N
authors: Meuleman
authors: Beatrice
authors: B
authors: Thielemans
authors: Laurent
authors: L
authors: Garderet
authors: Bruno
authors: B
authors: Royer
authors: Cyrille
authors: C
authors: Hulin
authors: Lotfi
authors: L
authors: Benboubker
authors: Olivier
authors: O
authors: Decaux
authors: Martine
authors: M
authors: Escoffre-Barbe
authors: Mauricette
authors: M
authors: Michallet
authors: Denis
authors: D
authors: Caillot
authors: Jean Paul
authors: JP
authors: Fermand
authors: Hervé
authors: H
authors: Avet-Loiseau
authors: Thierry
authors: T
authors: Facon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage*; D000069286:Bortezomib; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005602:France; D006801:Humans; D000077269:Lenalidomide; D008495:Medical Oncology / Q000458:organization & administration; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D011719:Pyrazines / Q000008:administration & dosage*; D012955:Societies, Medical; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; C467566:pomalidomide; D000077269:Lenalidomide