Abstract
Patients with multiple myeloma who have relapsed after or become refractory to lenalidomide in early treatment lines represent a clinically important population in need of effective therapies. The safety and efficacy of pomalidomide, low-dose dexamethasone, and daratumumab was evaluated in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM) after one to two prior treatment lines in the phase 2 MM-014 study. Patients received pomalidomide 4 mg daily from days 1–21 and dexamethasone 40 mg weekly (28-day cycles). Daratumumab 16 mg/kg was administered per label. Primary endpoint was overall response rate (ORR); secondary endpoints included progression-free survival (PFS) and safety. Per protocol, all patients (N = 112) had received lenalidomide in their most recent prior regimen (75.0% lenalidomide refractory). ORR was 77.7% (76.2% in lenalidomide-refractory patients); median follow-up was 17.2 months. Median PFS was not reached (1-year PFS rate 75.1%). The most common hematologic grade 3/4 treatment-emergent adverse event was neutropenia (62.5%). Grade 3/4 infections were reported in 31.3% of patients, including 13.4% with grade 3/4 pneumonia. These results demonstrate the safety and efficacy of pomalidomide-based therapy as early as second line in patients with RRMM, even immediately after lenalidomide failure, indicating that switching from the immunomodulatory agent class is not necessary.
Highlights
Supplementary information The online version of this article contains supplementary material, which is available to authorized users.John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USADavid Geffen School of Medicine at University of California, Los Angeles, CA, USACleveland Clinic, Cleveland, OH, USA 4 McGill University Health Centre, Montreal, QC, Canada 5 Sarah Cannon Research Institute, Nashville, TN, USA 6 The University of Kansas Cancer Center, Fairway, KS, USA 7 Colorado Blood Cancer Institute, Denver, CO, USA 8 Vancouver General Hospital, Vancouver, BC, CanadaAdvances in therapy have led to improved survival in multiple myeloma (MM); nearly every patient will relapse following initial treatment [1,2,3]
Lenalidomide-based regimens, patients with lenalidomiderefractory disease have been poorly represented in recent phase 3 relapsed or refractory MM (RRMM) clinical trials [1, 4,5,6,7,8,9]
Patients had either one (n = 70; 62.5%) or two prior lines of therapy (n = 42; 37.5%), and all patients were treated with lenalidomide in the immediate prior line of Assessed for eligibility (n = 134)
Summary
Lenalidomide-based regimens, patients with lenalidomiderefractory disease have been poorly represented in recent phase 3 relapsed or refractory MM (RRMM) clinical trials [1, 4,5,6,7,8,9]. Management of these patients remains challenging due to the availability of multiple treatment options combined with factors such as disease aggressiveness, patient age, and response to previous antimyeloma therapies [3, 10]. Patients who have become refractory to lenalidomide in early treatment lines are a clinically relevant population in need of proven and effective therapies [1, 4,5,6,7,8,9]
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