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Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment.

  • Author(s): 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
  • Bahlis, Nizar J
  • et al.
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.

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