drugset / Trial / NCT04150965

Summary

This a Phase I/II randomized trial for patients with relapsed refractory Multiple Myeloma who have relapsed after treatment with prior therapies. The protocol is designed to evaluate two agents, Anti-LAG-3 and Anti-TIGIT, in order to understand their immunologic effects and safety both as single agents and in combination with pomalidomide and dexamethasone. In these arms, patients will be treated with either Anti-LAG-3 or Anti-TIGIT respectively for one cycle as single agent followed by the addition of pomalidomide and dexamethasone in combination for subsequent cycles. A third arm allows patients to be treated with the FDA approved combination of elotuzumab plus pomalidomide and dexamethsone as a control. This arm will thus allow a concurrent standard of care comparator for the experimental arms.

Timeline

Start
2020-07-10
Primary completion
2024-08-30
Completion
2024-08-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Elotuzumab Monoclonal antibody
Subject RENVISTOBART Monoclonal antibody
Subject Relatlimab Monoclonal antibody
Background Dexamethasone Small molecule
Background Pomalidomide Other / unclassified