Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS) (POPLIN)
10. september 2026 oppdatert 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
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-post: clinicaltrials@regeneron.com
Studiesteder
-
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California
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Los Angeles, California, Forente stater, 90069
- Rekruttering
- Berenson Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Rekruttering
- Mary Bird Perkins Cancer Center
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Maryland
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Bethesda, Maryland, Forente stater, 20817
- Rekruttering
- American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
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Washington
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Tacoma, Washington, Forente stater, 98405
- Rekruttering
- NorthWest Medical Specialties, PLLC
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Linvoseltamab
|
Administrert i henhold til protokollen
Andre navn:
Administrert i henhold til protokollen
Andre navn:
|
Hva måler studien?
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse
Tidsramme: Inntil 12 måneder
|
Inntil 12 måneder
|
|
|
Varighet av respons (DOR)
Tidsramme: Inntil 12 måneder
|
Inntil 12 måneder
|
|
|
Progresjonsfri overlevelse (PFS)
Tidsramme: Inntil 12 måneder
|
Inntil 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juli 2026
Primær fullføring (Antatt)
11. oktober 2027
Studiet fullført (Antatt)
6. desember 2028
Datoer for studieregistrering
Først innsendt
20. mai 2026
Først innsendt som oppfylte QC-kriteriene
20. mai 2026
Først lagt ut (Faktiske)
27. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Systemisk inflammatorisk responssyndrom
- Betennelse
- Hematologiske sykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, plasmacelle
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Hemoragiske lidelser
- Sjokk
- Patologiske tilstander, tegn og symptomer
- Hemic og lymfatiske sykdommer
- Cytokinfrigjøringssyndrom
- Multippelt myelom
- tocilizumab
Andre studie-ID-numre
- R5458-HM-2514
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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