Pomalidomide plus low-dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure |
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| Authors: | David S. Siegel Gary J. Schiller Kevin W. Song Richy Agajanian Keith Stockerl-Goldstein Hakan Kaya Michael Sebag Christy Samaras Ehsan Malek Giampaolo Talamo Christopher S. Seet Jorge Mouro William E. Pierceall Faiza Zafar Weiyuan Chung Shankar Srinivasan Amit Agarwal Nizar J. Bahlis |
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| Affiliation: | 1. John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA;2. David Geffen School of Medicine at UCLA, Los Angeles, CA, USA;3. Vancouver General Hospital, Vancouver, BC, Canada;4. The Oncology Institute of Hope and Innovation, Downey, CA, USA;5. Washington University School of Medicine, St. Louis, MO, USA;6. Cancer Care Northwest, Spokane, WA, USA;7. McGill University Health Centre, Montreal, QC, Canada;8. Cleveland Clinic, Cleveland, OH, USA;9. University Hospitals Case Medical Center, Cleveland, OH, USA;10. Penn State Hershey Cancer Institute, Hershey, PA, USA;11. Celgene Corporation, Summit, NJ, USA;12. University of Calgary, Calgary, AB, Canada |
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| 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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| Keywords: | pomalidomide dexamethasone lenalidomide multiple myeloma refractory |
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