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

NCT07609940 | Recruiting Phase 4 FDA Drug

• 1 other identifier: R5458-HM-2514
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Cytokine Release Syndrome (CRS); Linvoseltamab; Tocilizumab; Bispecific antibodies

Outcome Measures

Primary Outcomes (2)

• Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading

  Up to 28 days

• Severity of any grade CRS per ASTCT grading

  Up to 28 days

Secondary Outcomes (30)

• Occurrence of CRS of any grade

  Up to 12 months

• Occurrence of recurrent CRS of any grade

  Up to 12 months

• Occurrence of grade ≥2 CRS per ASTCT grading

  Up to 12 months

• Occurrence of recurrent grade ≥2 CRS per ASTCT grading

  Up to 12 months

• Occurrence of any grade infections per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

  Up to 12 months

Study Arms (1)

Linvoseltamab

EXPERIMENTAL

Drug: Linvoseltamab; Drug: Tocilizumab

Interventions

Linvoseltamab DRUG

Administered per the protocol

Also known as: REGN5458, Lynozyfic™

Linvoseltamab

Tocilizumab DRUG

Administered per the protocol

Also known as: ACTEMRA®

Linvoseltamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 antibody
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
• Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

You may not qualify if:

• Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome
• Known myeloma brain lesions or meningeal involvement
• History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \[PML\], or Central Nervous System (CNS) movement disorder

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Cytokine Release Syndrome

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): October 11, 2027
• Study Completion (Estimated): December 6, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (2)