Pembrolizumab (MK-3475) in MM Patients With Residual Disease
Status:
Completed
Trial end date:
2020-02-20
Target enrollment:
Participant gender:
Summary
This is a national, multicenter, open label single-arm, non-comparative study that will
determine the efficacy, safety and the changes in selected pharmacodynamics markers of
MK-3475 monotherapy administered as consolidation therapy in MM patients who have achieved a
response with a previous treatment but who still display some residual disease.
For this purpose, 20 MM patients, who have received any treatment of limited duration either
at diagnosis or at first relapse, and that have achieved a good response (≥VGPR) but with
persistent residual disease (that is patients in VGPR, non-stringent CR, or MRD+ sCR), will
be treated with MK-3475 monotherapy administered iv at a dose of 200 mg every three weeks for
1 year, with a potential expansion of 1 additional year of treatment in case of clinical
benefit and patient agreement. Efficacy, safety and pharmacodynamic parameters will be
evaluated to understand the role of this monoclonal antibody in this setting.