Leukemia : official journal of the Leukemia Society of America, Leukemia Research Fund, U.K
texas; lubbock; joe arrington; Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Female; Humans; Lenalidomide; Male; Multiple Myeloma; Neoplasm Recurrence, Local; Progression-Free Survival; Thalidomide
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.
Siegel, David S; Schiller, Gary J; Samaras, Christy; Sebag, Michael; Berdeja, Jesus; Ganguly, Siddhartha; Matous, Jeffrey; Song, Kevin; Seet, Christopher S; Talamo, Giampaolo; Acosta-Rivera, Mirelis; Bar, Michael; Quick, Donald; Anz, Bertrand; Fonseca, Gustavo; Reece, Donna; Pierceall, William E; Chung, Weiyuan; Zafar, Faiza; Agarwal, Amit; and Bahlis, Nizar J, "Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment." (2020). Articles, Abstracts, and Reports. 4329.