A phase II trial of lenalidomide, bortezomib and dexamethasone in patients with relapsed and relapsed/refractory myeloma
Mené sur 64 patients atteints d'un myélome multiple récidivant ou réfractaire, cet essai de phase II évalue l'efficacité, du point de vue de la survie sans progression, et la toxicité d'un traitement combinant lénalidomide, dexaméthasone et bortezomib
In this prospective, multicenter, phase 2 study, 64 patients with relapsed or relapsed and refractory multiple myeloma (MM) received up to eight 21-day cycles of bortezomib 1.0 mg/m2 (days 1, 4, 8, 11), lenalidomide 15 mg/day (days 1-14), and dexamethasone 40/20 mg/day (cycles 1-4) and 20/10 mg/day (cycles 5-8) (days of/after bortezomib dosing). Responding patients could receive maintenance therapy. Median age was 65 years, 66% were male, 58% had relapsed and 42% relapsed and refractory MM, and 53%, 75%, and 6% had received prior bortezomib, thalidomide, and lenalidomide, respectively. Forty eight of 64 patients (75%; 90% CI, 65-84) were alive without progressive disease at 6 months (primary endpoint). The rate of partial response or better was 64%; median duration of response was 8.7 months. Median progression-free and overall survival were 9.5 and 30 months, respectively (median follow-up: 44 months). Common treatment-related toxicities included sensory neuropathy (53%), fatigue (50%), and neutropenia (42%); common grade 3/4 treatment-related toxicities included neutropenia (30%), thrombocytopenia (22%), and lymphopenia (11%). Grade 3 motor neuropathy was reported in two patients. Lenalidomide-bortezomib-dexamethasone appears effective and tolerable in patients with relapsed or relapsed and refractory MM, demonstrating substantial activity among patients with diverse prior therapies and adverse prognostic characteristics. This trial is registered with www.ClinicalTrials.gov as #NCT00378209.