Abstract
OBJECTIVES: Lenalidomide and low-dose dexamethasone (Rd) is a standard regimen for transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM), for whom a multi-drug treatment regimen is not considered appropriate. While Rd has been intensively investigated in clinical trials, prospective real-world data are still scarce. PATIENTS AND METHODS: The prospective, multicenter, non-interventional study FIRST-NIS (NTC02537808) investigated the effectiveness, safety, and quality of life (QoL) of Rd in a German real-world setting. G8-Geriatric assessment was used to assess patients' impairment status. Patients were treated according to the physician's discretion. Data were analyzed descriptively; no formal hypothesis was tested. RESULTS: Between 2015 and 2018, 168 patients with TIE NDMM were included, median age was 77.7 years. With a median follow-up of 64.2 months, median progression-free survival (PFS) in the real-world setting was 22.9 months [95% CI 19.3, 28.1], median overall survival (OS) 58.1 months [95% CI 45.7, 71.7]. Patients ≤ 75 years and non-impaired patients showed a more favorable PFS and OS, and Rd was a feasible treatment option in most patients with renal impairment. QoL was maintained during Rd treatment. No new safety signals emerged. CONCLUSIONS: The results of the FIRST-NIS support Rd as an effective and safe frontline treatment option for patients with TIE NDMM, irrespective of age, with similar clinical outcomes in the real world compared to the pivotal trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02537808.