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

NCT07609940 — Phase 4, Recruiting, 30 participants, Regeneron Pharmaceuticals

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A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed/Refractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting

Registry	NCT07609940, acronym POPLIN
Status	Recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Regeneron Pharmaceuticals (Industry)
Conditions	Relapsed/Refractory Multiple Myeloma (RRMM)
Interventions	Linvoseltamab, Tocilizumab (Drug)
Dates	start 2026-07-15, primary completion 2027-10-11 (estimated), completion 2028-12-06 (estimated), first posted 2026-05-27, last updated 2026-09-25
Locations	5 sites in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Linvoseltamab	Experimental	Drug: Linvoseltamab; Drug: Tocilizumab

Linvoseltamab (Drug), also known as REGN5458, Lynozyfic™: Administered per the protocol
Tocilizumab (Drug), also known as ACTEMRA®: Administered per the protocol

+Outcome measures

Primary outcomes

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

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]: NCI CTCAE grade 1 to 5 version 5.0
Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0 [Up to 12 months]
Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading [Up to 12 months]
Occurrence of grade ≥3 ICANS per ASTCT grading [Up to 12 months]
Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading [Up to 12 months]
Occurrence of any grade neurotoxicity per ASTCT grading [Up to 12 months]
Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading [Up to 12 months]
Occurrence of grade ≥3 neurotoxicity per ASTCT grading [Up to 12 months]
Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading [Up to 12 months]
Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading [Up to 12 months]
Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS [Up to 12 months]
Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS [Up to 12 months]
Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS [Up to 12 months]
Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab [Up to 12 months]
Total length of each Adverse Event (AE)-related hospital stay [Up to 12 months]
Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab [Up to 12 months]
Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab [Up to 12 months]
Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab [Up to 12 months]
Severity of AESI in participants treated with at least 1 dose of linvoseltamab [Up to 12 months]
Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab [Up to 12 months]
Severity of SAEs in participants treated with at least 1 dose of linvoseltamab [Up to 12 months]
Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria [Up to 12 months]
Duration Of Response (DOR) [Up to 12 months]
Progression-Free Survival (PFS) [Up to 12 months]
Overall Survival [Up to 12 months]
Time To Response (TTR) [Up to 12 months]

+Eligibility

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

1. 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
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Key Exclusion Criteria:

1. 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
2. Known myeloma brain lesions or meningeal involvement
3. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \[PML\], or Central Nervous System (CNS) movement disorder

NOTE: Other protocol defined inclusion/exclusion criteria apply

+Locations (5)

Facility	City	Country	Status
Berenson Cancer Center	Los Angeles, California	United States	Recruiting
Comprehensive Hematology Oncology	St. Petersburg, Florida	United States	Recruiting
Mary Bird Perkins Cancer Center	Baton Rouge, Louisiana	United States	Recruiting
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders	Bethesda, Maryland	United States	Recruiting
Northwest Medical Specialties, PLLC	Tacoma, Washington	United States	Recruiting

+Investigators

Clinical Trial Management, Study director, Regeneron Pharmaceuticals