Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

20. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Linvoseltamab
Medicin: Linvoseltamab
Administreret pr. Protokol
Andre navne:
  • REGN5458
  • Lynozyfic ™
Medicin: Tocilizumab
Administreret pr. Protokol
Andre navne:
  • ACTEMRA®

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse
Tidsramme: Op til 12 måneder
Op til 12 måneder
Varighed af svar (DOR)
Tidsramme: Op til 12 måneder
Op til 12 måneder
Progressionsfri overlevelse (PFS)
Tidsramme: Op til 12 måneder
Op til 12 måneder
Occurrence of CRS of any grade
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of recurrent CRS of any grade
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of grade ≥2 CRS per ASTCT grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of recurrent grade ≥2 CRS per ASTCT grading
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of any grade Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) per ASTCT grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 ICANS per ASTCT grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of any grade neurotoxicity per NCI-CTCAE version 5.0 grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of any grade neurotoxicity per ASTCT grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neurotoxicity per NCI-CTCAE version 5.0 grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neurotoxicity per ASTCT grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of any grade neutropenia per NCI-CTCAE version 5.0 grading
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of grade ≥3 neutropenia per NCI-CTCAE version 5.0 grading
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 12 months
Up to 12 months
Total duration of corticosteroid treatment following at least 1 dose of linvoseltamab for the management CRS
Tidsramme: Up to 12 months
Up to 12 months
Number of hospitalizations per participant treated with at least 1 dose of linvoseltamab
Tidsramme: Up to 12 months
Up to 12 months
Total length of each Adverse Event (AE)-related hospital stay
Tidsramme: 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
Tidsramme: Up to 12 months
Up to 12 months
Severity of TEAEs in participants treated with at least 1 dose of linvoseltamab
Tidsramme: 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
Tidsramme: Up to 12 months
Up to 12 months
Severity of AESI in participants treated with at least 1 dose of linvoseltamab
Tidsramme: Up to 12 months
Up to 12 months
Occurrence of Serious Adverse Events (SAEs) in participants treated with at least 1 dose of linvoseltamab
Tidsramme: Up to 12 months
Up to 12 months
Severity of SAEs in participants treated with at least 1 dose of linvoseltamab
Tidsramme: Up to 12 months
Up to 12 months
Achievement of Partial Response or better (≥PR) per International Myeloma Working Group (IMWG) criteria
Tidsramme: Up to 12 months
Up to 12 months
Time To Response (TTR)
Tidsramme: Up to 12 months
Up to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Efterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

17. juli 2026

Primær færdiggørelse (Anslået)

11. oktober 2027

Studieafslutning (Anslået)

6. december 2028

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R5458-HM-2514

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Recidiverende/Refraktær Myelom (RRMM)

Kliniske forsøg med Linvoseltamab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Trinidad & Tobago

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner