NCT04150965

Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT

A Phase I/II Assessment of Combination Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 (BMS-986016) and Anti-TIGIT (BMS-986207)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Multiple Myeloma Research Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll 104 patients to one of three treatment arms. The study is open to patients relapsing with refractory Multiple Myeloma who have: * received 3 prior lines of therapy * exposed to each of these 3 drug classes: * IMiD * proteasome inhibitors, and * anti-CD38 monoclonal antibody * relapsed and refractory are defined using the IMWG criteria: * disease that is non-responsive while on salvage therapy or progresses within 60 days of last therapy in patients who have achieved minimal response or better at some point previously to then progressing in their disease course.

Conditions

• Multiple Myeloma
• Relapsed Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elotuzumab, pomalidomide, dexamethasone	Study Patients with relapsed Multiple Myeloma will receive: Elotuzumab, Pomalidomide, and Dexamethasone Starting in Phase 2 Cycle 1 Day 1 forward. Each cycle is 28 days long.
DRUG	Anti-LAG-3	Patients with relapsed Multiple Myeloma will receive: Anti -LAG-3 single agent for Cycle 1. Each Cycle is 28 days Cycle 2 forward patients will receive Anti-LAG-3 in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days long.
DRUG	Anti-LAG-3 + Pomalidimide + Dexamethasone	Patients with Relapsed \& Refractory Multiple Myeloma will receive: Anti-LAG-3 in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days.
DRUG	Anti-TIGIT	Patients with relapsed Multiple Myeloma will receive: Anti -TIGIT single agent for Cycle 1. Each cycle is 28 days.
DRUG	Anti-TIGIT + Pomalidimide + Dexamethasone	Cycle 2 and beyond patients will receive Anti-TIGIT in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days..

Timeline

• Start date: 2020-07-10
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2019-11-05
• Last updated: 2025-02-14

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study