J Clin Oncol 31, 2013 (suppl; abstr 8532)
Sundar Jagannath, Craig C. Hofmeister, Rachid C. Baz, David Samuel DiCapua Siegel, Ravi Vij, Christine Chen, Sagar Lonial, Kenneth Carl Anderson, Min Chen, Mohamed H. Zaki, Paul Gerard Guy Richardson; Mount Sinai Medical Center, New York, NY; Ohio State University Medical Center, Columbus, OH; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ; Washington University in St. Louis, St Louis, MO; Princess Margaret Hospital, Toronto, ON, Canada; Emory University School of Medicine, Atlanta, GA; Dana-Farber Cancer Institute, Boston, MA; Celgene Corporation, Summit, NJ
Background: POM demonstrated clinical efficacy and favorable tolerability in RRMM pts previously treated with lenalidomide (LEN) and bortezomib (BORT), in the randomized, multicenter, open label MM-002 phase II trial. This analysis evaluated whether the efficacy and tolerability of POM+LoDEX treatment is consistent across age subgroups.
Methods: Pts with RRMM who had received ≥ 2 prior therapies, including LEN and BORT, and were refractory to their last regimen were randomized to either POM+LoDEX (POM 4 mg/day, days 1–21 of a 28-day cycle; LoDEX 40 mg/week) or POM alone. End points included progression-free survival (PFS), response rate (based on EBMT criteria), response duration, and safety. A post-hoc analysis based on age (≤ 65 vs. > 65 yrs) was conducted.
Results: A total of 221 pts with a mean age of 64 yrs (range 34–88) were randomized to POM+LoDEX (n = 113) or POM (n = 108). The efficacy outcomes and the most common treatment emergent grade 3/4 adverse events (AEs) for the age subgroups according to treatment arm are presented in the Table.
Conclusions: Regardless of age (≤ 65 vs. > 65 yrs), POM with or without LoDEX was effective and generally well tolerated in heavily pretreated RRMM pts who had already received LEN and BORT. POM with or without LoDEX represents a new clinical option for pts previously treated with numerous lines of therapy. Updated data will be presented at the meeting.
Clinical trial information: NCT00833833