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Pomalidomide plus low-dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure.

  • Author(s): Siegel, David S;
  • Schiller, Gary J;
  • Song, Kevin W;
  • Agajanian, Richy;
  • Stockerl-Goldstein, Keith;
  • Kaya, Hakan;
  • Sebag, Michael;
  • Samaras, Christy;
  • Malek, Ehsan;
  • Talamo, Giampaolo;
  • Seet, Christopher S;
  • Mouro, Jorge;
  • Pierceall, William E;
  • Zafar, Faiza;
  • Chung, Weiyuan;
  • Srinivasan, Shankar;
  • Agarwal, Amit;
  • Bahlis, Nizar J
  • et al.

Published Web Location

https://doi.org/10.1111/bjh.16213
Abstract

Patients with relapsed/refractory multiple myeloma (RRMM) for whom the benefits of lenalidomide have been exhausted in early treatment lines need effective therapies. In cohort A of the phase 2 MM-014 trial, we examined the safety and efficacy of pomalidomide plus low-dose dexamethasone immediately after lenalidomide-based treatment failure in patients with RRMM and two prior lines of therapy. Pomalidomide 4 mg was given on days 1 to 21 of 28-day cycles. Dexamethasone 40 mg (20 mg for patients aged >75 years) was given on days 1, 8, 15 and 22 of 28-day cycles. The primary endpoint was overall response rate (ORR), and secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The intention-to-treat population comprised 56 patients; all received prior lenalidomide (87·5% lenalidomide refractory) and 39 (69·6%) received prior bortezomib. ORR was 32·1% (28·2% in the prior-bortezomib subgroup). Median PFS was 12·2 months (7·9 months in the prior-bortezomib subgroup). Median OS was 41·7 months (38·6 months in the prior-bortezomib subgroup). The most common grade 3/4 treatment-emergent adverse events were anaemia (25·0%), pneumonia (14·3%) and fatigue (14·3%). These findings support earlier sequencing of pomalidomide-based therapy in lenalidomide-pretreated patients with RRMM, including those who have become refractory to lenalidomide. Trial registration: www.ClinicalTrials.gov identifier NCT01946477.

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