Safety and Efficacy of Combination Maintenance Therapy with Ixazomib and Lenalidomide in Post-transplant Myeloma Patients
Mené sur 64 patients atteints d'un myélome multiple récemment diagnostiqué (durée médiane de suivi : 62 mois), cet essai évalue l'efficacité, du point de vue du taux de réponse et de la survie sans progression, et la toxicité d'un traitement d'entretien combinant ixazomib et lénalidomide après une greffe autologue de cellules souches
Purpose: In this study, the addition of ixazomib to lenalidomide maintenance post- autologous stem cell transplant (ASCT) in 64 newly diagnosed multiple myeloma (NDMM) patients was evaluated based on the observed benefit of lenalidomide-only maintenance in prior studies. Methods: Patients were started on maintenance therapy with lenalidomide and ixazomib within 60-180 days of stem cell infusion. Results: Response rates deepened over time from baseline post-ASCT for 39 patients. The complete response (CR)/stringent CR rate was 43% and median overall survival was not reached with a median follow-up of 62 months (range 25-82 months). Median PFS (mPFS) for all patients was 73 months and has not been reached for those with ISS stage 1 disease. mPFS in 9 patients who had ISS stage 3 disease and 14 patients who had high-risk cytogenetics was 34 and 25 months, respectively. Twenty-two patients had progressive disease, while 19 patients continue to receive dual maintenance. The most common grade 3/4 adverse events included neutropenia, leukopenia, thrombocytopenia, lung infections, diarrhea, and maculopapular rash. Second primary malignancies occurred in 9 patients. Toxicity led to dose reductions in ixazomib and lenalidomide in 20 and 31 patients, respectively. Discontinuation of ixazomib due to toxicity occurred in 4 patients. Grade 1/2 neuropathy occurred in 22 patients and led to reduction or discontinuation of ixazomib in 2 patients. Conclusions: The addition of ixazomib to lenalidomide maintenance demonstrated a better than expected PFS compared with historical data using lenalidomide alone and was safe and tolerable.