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

10 september 2026 uppdaterad av: Regeneron Pharmaceuticals

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

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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90069
        • Rekrytering
        • Berenson Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna, 70809
        • Rekrytering
        • Mary Bird Perkins Cancer Center
    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20817
        • Rekrytering
        • American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
    • Washington
      • Tacoma, Washington, Förenta staterna, 98405
        • Rekrytering
        • NorthWest Medical Specialties, PLLC

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Linvoseltamab
Läkemedel: Linvoseltamab
Administreras per protokollet
Andra namn:
  • REGN5458
  • Lynozyfic ™
Läkemedel: Tocilizumab
Administreras per protokollet
Andra namn:
  • ACTEMRA®

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading
Tidsram: Up to 28 days
Up to 28 days
Severity of any grade CRS per ASTCT grading
Tidsram: Up to 28 days
Up to 28 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total överlevnad
Tidsram: Upp till 12 månader
Upp till 12 månader
Duration of Response (DOR)
Tidsram: Upp till 12 månader
Upp till 12 månader
Progressionsfri överlevnad (PFS)
Tidsram: Upp till 12 månader
Upp till 12 månader
Occurrence of CRS of any grade
Tidsram: Up to 12 months
Up to 12 months
Occurrence of recurrent CRS of any grade
Tidsram: Up to 12 months
Up to 12 months
Occurrence of grade ≥2 CRS per ASTCT grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of recurrent grade ≥2 CRS per ASTCT grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of any grade infections per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Tidsram: Up to 12 months
NCI CTCAE grade 1 to 5 version 5.0
Up to 12 months
Occurrence of grade ≥3 infections per NCI-CTCAE version 5.0
Tidsram: Up to 12 months
Up to 12 months
Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 ICANS per ASTCT grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of any grade neurotoxicity per ASTCT grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neurotoxicity per ASTCT grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading
Tidsram: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading
Tidsram: Up to 12 months
Up to 12 months
Number of treatment doses of tocilizumab following at least 1 dose of linvoseltamab for the management CRS
Tidsram: Up to 12 months
Up to 12 months
Number of treatment doses of corticosteroid following at least 1 dose of linvoseltamab for the management CRS
Tidsram: Up to 12 months
Up to 12 months
Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS
Tidsram: Up to 12 months
Up to 12 months
Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab
Tidsram: Up to 12 months
Up to 12 months
Total length of each Adverse Event (AE)-related hospital stay
Tidsram: Up to 12 months
Up to 12 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs) in participants treated with at least 1 dose of linvoseltamab
Tidsram: Up to 12 months
Up to 12 months
Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab
Tidsram: Up to 12 months
Up to 12 months
Occurrence of Adverse Events of Special Interest (AESI) in participants treated with at least 1 dose of linvoseltamab
Tidsram: Up to 12 months
Up to 12 months
Severity of AESI in participants treated with at least 1 dose of linvoseltamab
Tidsram: Up to 12 months
Up to 12 months
Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab
Tidsram: Up to 12 months
Up to 12 months
Severity of SAEs in participants treated with at least 1 dose of linvoseltamab
Tidsram: Up to 12 months
Up to 12 months
Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria
Tidsram: Up to 12 months
Up to 12 months
Time To Response (TTR)
Tidsram: Up to 12 months
Up to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Regeneron Pharmaceuticals

Utredare

  • Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 juli 2026

Primärt slutförande (Beräknad)

11 oktober 2027

Avslutad studie (Beräknad)

6 december 2028

Studieregistreringsdatum

Först inskickad

20 maj 2026

Först inskickad som uppfyllde QC-kriterierna

20 maj 2026

Första postat (Faktisk)

27 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • R5458-HM-2514

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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