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