1. Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment
- Author
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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
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Sciences ,Oncology and Carcinogenesis ,Hematology ,Clinical Research ,Rare Diseases ,Cancer ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Aged ,Antibodies ,Monoclonal ,Antineoplastic Combined Chemotherapy Protocols ,Dexamethasone ,Female ,Humans ,Lenalidomide ,Male ,Multiple Myeloma ,Neoplasm Recurrence ,Local ,Progression-Free Survival ,Thalidomide ,Immunology ,Cardiovascular medicine and haematology ,Clinical sciences ,Oncology and carcinogenesis - 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.
- Published
- 2020