Abstract

Background: Patients with relapsed or refractory multiple myeloma (RRMM) who have exhausted lenalidomide benefits require improved therapies. The 3-cohort phase 2 MM-014 trial (NCT01946477) explored pomalidomide in early lines of treatment for lenalidomide-exposed RRMM. In cohort B, pomalidomide plus daratumumab and dexamethasone (DPd) showed promising efficacy (median follow-up 28.4 months), as previously reported. Here, we report final overall survival (OS) in cohort B.Methods: Patients aged ≥18 years were treated in 28-day cycles: pomalidomide 4 mg orally daily from days 1–21; daratumumab 16 mg/kg intravenously on days 1, 8, 15, and 22 (cycles 1–2), days 1 and 15 (cycles 3–6), and day 1 (cycle ≥7); and dexamethasone 40 mg (age ≤75 years) or 20 mg (age >75 years) orally on days 1, 8, 15, and 22. The primary endpoint was ORR. OS and safety were secondary endpoints.Results: Among 112 patients enrolled, 85 (75.9%) had lenalidomide-refractory disease and 27 (24.1%) had lenalidomide-relapsed disease. At a median follow-up of 41.9 months (range, 0.4–73.1), median OS was 56.7 months (95% confidence interval, 46.5–not reached). Treatment-emergent adverse events related to, and leading to discontinuation of, pomalidomide, dexamethasone, or daratumumab occurred in 7 (6.3%), 9 (8.0%), and 6 (5.4%) patients, respectively.Conclusion: With long-term follow-up, our results show favorable OS with DPd. The safety profile was consistent with previous reports, with no new safety signals were identified. IMiD agent-based therapy can still be considered in patients with RRMM who experience progressive disease on or after lenalidomide.