pembrolizumab plus pomalidomide and dexamethasone (n=125) vs. pomalidomide and dexamethasone (n=124)
randomized controlled trial
pembrolizumab plus pomalidomide and dexamethasone
pembrolizumab 200 mg every 3 weeks
pomalidomide and dexamethasone
pomalidomide and dexamethasone (pomalidomide 4 mg daily on days 1–21 and oral low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 in 28-day cycles)
multiple myeloma - 2nd line (L2)
open label
97 medical centres across 11 countries
P3/one sided and two interim analysis. Repartition between coprimary endpoint and reallocation (ORR with PFS and PFS with OS)
the FDA halted KEYNOTE-183 on the basis of interim data presented to the data monitoring committee, which indicated that the risks associated with the pembrolizumab combination outweighed the benefits