Overview

A Study to Learn How Linvoseltamab (REGN5458) Will Work Compared to the Elotuzumab, Pomalidimide and Dexamethasone (EPd) Combination, in Participants With Relapsed/Refractory Multiple Myeloma

Status:
Not yet recruiting

Trial end date:
2032-10-22

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to compare progression-free survival (PFS) per the Independent Review Committee (IRC) between participants treated with linvoseltamab monotherapy and EPd. The key secondary objectives are: - To compare the anti-tumor activity per IRC between linvoseltamab monotherapy and EPd as measured by - objective response - ≥very good partial response (VGPR) - ≥ complete response (CR) - To compare the incidence of minimal residual disease (MRD) negative status (10^-5) in the bone marrow between linvoseltamab monotherapy and EPd - To compare overall survival (OS) between linvoseltamab monotherapy and EPd - To evaluate the treatment effects on pain symptom between linvoseltamab monotherapy and EPd Other secondary objectives include: - To evaluate the safety and tolerability of linvoseltamab monotherapy compared to EPd - To compare PFS per the investigator between participants treated with linvoseltamab monotherapy and EPd. - To compare the anti-tumor activity per the investigator between linvoseltamab monotherapy and EPd as measured by - Objective response - ≥VGPR - ≥CR - To evaluate duration of response (DOR) per investigator and IRC for participants achieving objective response on linvoseltamab monotherapy and on EPd - To evaluate the duration of MRD negative status in the bone marrow in participants receiving linvoseltamab monotherapy and EPd - To evaluate the time to response for participants with response ≥PR for linvoseltamab monotherapy and EPd - To evaluate the pharmacokinetics (PK) of linvoseltamab - To evaluate the immunogenicity of linvoseltamab - To evaluate the effects on patient reported quality of life (QoL), functioning and symptoms between linvoseltamab monotherapy and EPd

Phase:

Phase 3

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Treatments:

Dexamethasone
Elotuzumab
Pomalidomide