Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma
Mené sur 97 patients atteints d'un myélome multiple récidivant, cet essai de phase II évalue l'efficacité, du point de vue de la rémission, partielle ou complète après 4 cycles de traitements, et la toxicité d'un traitement à base de pomalidomide, cyclophosphamide et dexaméthasone, après l'échec d'un traitement combinant lénalidomide, bortézomib et dexaméthasone, dispensé avec ou sans greffe autologue de cellules souches hématopoïétiques
Pomalidomide, cyclophosphamide, dexamethasone (PCD) in first relapse after exposure to lenalidomide and bortezomib is efficacious and safe.Salvage PCD can be a bridge for delayed autologous stem cell transplantation. <pIt is important to have an effective therapy for multiple myeloma (MM) patients at first relapse, particularly if an autologous stem cell transplant (ASCT) is considered at this stage. This multicenter, phase II trial evaluated the efficacy and safety of weekly oral pomalidomide-cyclophosphamide-dexamethasone (PCD) in MM patients in first relapse after treatment with lenalidomide-bortezomib-dexamethasone (RVD). All patients had received RVD as induction and consolidation therapy, plus lenalidomide maintenance for 1 year (Arm A). Half had also received an ASCT after induction (Arm B). At MM relapse, all patients received four oral cycles of pomalidomide 4 mg (Days 1-21), cyclophosphamide 300 mg (Days 1, 8, 15 and 22), and dexamethasone 40 mg (Days 1-4 and Days 15-18 of a 28-day cycle) (PCD). Responding patients in Arm A underwent ASCT and received two additional cycles of PCD, while those in Arm B received five cycles of PCD. All patients received pomalidomide-dexamethasone maintenance until disease progression. Primary endpoint was partial remission or better after the initial four cycles of PCD. Responses were obtained in 82/97 (85%) patients evaluated: complete remission (n=1; 1%); very good partial remission (n=32; 33%); partial remission (PR) (n=49; 51%). Three patients (3%) had stable disease and six (6%) had disease progression (6 response failures). Forty-five of the 48 patients (94%) in Arm A underwent planned ASCT. PCD was effective therapy after first relapse with RVD. After four cycles, the rate of PR or better was 85%, and 94% of planned ASCTs were performed. Toxicity was mostly hematologic and manageable. This trial was registered at www.clinicaltrials.gov, NCT02244125.