Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02
Mené sur 50 patients atteints d'un myélome multiple réfractaire/récidivant (âge médian : 63 ans), cet essai évalue l'efficacité d'un traitement combinant pomalidomide et dexaméthasone à faible dose en fonction de la présence d'une délétion 17p ou d'une translocation (4;14)
The combination of pomalidomide and low-dose dexamethasone (Pom-Dex) can be safely administered to patients with end stage relapsed/refractory multiple myeloma (RRMM). However, we observed a shorter median PFS and OS for these patients when characterized with adverse cytogenetics (deletion 17p and translocation (4;14)) in the IFM 2009-02 trial. We then sought to determine whether MM with adverse cytogenetic would benefit greater to Pom-Dex if exposed earlier in the multicenter IFM 2010-02. The ITT population included 50 patients, with median age 63 years, 38% ≥65. The TTP was 2.8 months; interestingly, with a striking difference according to presence of t(4;14) compared to del(17p), 7.3 versus 2.8 months; similarly to the DOR, 8.3 and 2.4 months, and the ORR, 32% versus 15%, respectively. Interestingly, the OS was prolonged after Pom-Dex, particularly in t(4;14) given the short TTP, suggesting that patients were rescued at relapse with further lines of therapy. Pomalidomide plus low dose dexamethasone, a doublet IMiDs-based regimen, is active and well tolerated in adverse cytogenetic patients with early RRMM, particularly with del(17p), characterized with high and rapid development of a refractoriness state, and known for their poor prognosis. Future studies will determine the underlying mechanisms of Pom-Dex activity in del(17p). This trial is registered at www.ClinicalTrials.gov (No. NCT01745640).