pembrolizumab plus lenalidomide and dexamethasone (n=151) vs. lenalidomide and dexamethasone (n=150)
randomized controlled trial
pembrolizumab plus lenalidomide and dexamethasone
pembrolizumab 200 mg intravenously every 3 weeks plus oral lenalidomide and oral low-dose dexamethasone (as 25 mg daily on days 1–21 and dexamethasone as 40 mg daily on days 1, 8, 15, and 22 of repeated 28-day cycles).
lenalidomide and dexamethasone
oral lenalidomide and oral low-dose dexamethasone (as 25 mg daily on days 1–21 and dexamethasone as 40 mg daily on days 1, 8, 15, and 22 of repeated 28-day cycles)
Cross-over between the arms is not permitted in the study.
multiple myeloma - 1st line (L1)
open
95 medical centres across 15 countries
P3/ one sided and one interim analysis. Hierarchy and reallocation alpha from PFS to OS
The results from this unplanned, FDA-requested, interim analysis showed that the benefit–risk profile of pembrolizumab plus lenalidomide and dexamethasone is unfavourable for patients with newly diagnosed, previously untreated multiple myeloma
KEYNOTE-183, 2019 NCT02576977
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