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NCT Number: NCT07609940

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

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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Key information

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM) Blood Protein Disorders Cardiovascular Diseases Cytokine Release Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Inflammation Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

Linvoseltamab

Drug

Administered per the protocol

Other names: REGN5458, Lynozyfic™

Tocilizumab

Drug

Administered per the protocol

Other names: ACTEMRA®

Primary outcomes

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

    Time frame: Up to 28 days

  2. Severity of any grade CRS per ASTCT grading

    Time frame: Up to 28 days

Secondary outcomes

  1. Occurrence of CRS of any grade

    Time frame: Up to 12 months

  2. Occurrence of recurrent CRS of any grade

    Time frame: Up to 12 months

  3. Occurrence of grade ≥2 CRS per ASTCT grading

    Time frame: Up to 12 months

  4. Occurrence of recurrent grade ≥2 CRS per ASTCT grading

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

    NCI CTCAE grade 1 to 5 version 5.0

  6. Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0

    Time frame: Up to 12 months

  7. Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading

    Time frame: Up to 12 months

  8. Occurrence of grade ≥3 ICANS per ASTCT grading

    Time frame: Up to 12 months

  9. Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading

    Time frame: Up to 12 months

  10. Occurrence of any grade neurotoxicity per ASTCT grading

    Time frame: Up to 12 months

  11. Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading

    Time frame: Up to 12 months

  12. Occurrence of grade ≥3 neurotoxicity per ASTCT grading

    Time frame: Up to 12 months

  13. Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading

    Time frame: Up to 12 months

  14. Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading

    Time frame: Up to 12 months

  15. Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS

    Time frame: Up to 12 months

  16. Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS

    Time frame: Up to 12 months

  17. Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS

    Time frame: Up to 12 months

  18. Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab

    Time frame: Up to 12 months

  19. Total length of each Adverse Event (AE)-related hospital stay

    Time frame: Up to 12 months

  20. Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab

    Time frame: Up to 12 months

  21. Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab

    Time frame: Up to 12 months

  22. Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab

    Time frame: Up to 12 months

  23. Severity of AESI in participants treated with at least 1 dose of linvoseltamab

    Time frame: Up to 12 months

  24. Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab

    Time frame: Up to 12 months

  25. Severity of SAEs in participants treated with at least 1 dose of linvoseltamab

    Time frame: Up to 12 months

  26. Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 12 months

  27. Duration Of Response (DOR)

    Time frame: Up to 12 months

  28. Progression-Free Survival (PFS)

    Time frame: Up to 12 months

  29. Overall Survival

    Time frame: Up to 12 months

  30. Time To Response (TTR)

    Time frame: Up to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: POPLIN

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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