MedTrace Logo

Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)

NCT07609940 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-27

No results posted yet for this study

Summary

This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody.

The aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab.

The study is looking at several other research questions, including:

* What side effects may happen from taking tocilizumab before the first dose of linvoseltamab
* Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last
* How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed

Conditions

  • Relapsed/Refractory Multiple Myeloma (RRMM)

Interventions

DRUG

Linvoseltamab

Administered per the protocol

DRUG

Tocilizumab

Administered per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-17
Primary Completion
2027-10-11
Completion
2028-12-06
FDA Drug
Yes

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07609940 on ClinicalTrials.gov