- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07825064
Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma
14. september 2026 oppdatert av: Hoffmann-La Roche
A Phase II, Single Arm, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone in Patients With Multiple Myeloma Who Have Received a Prior BCMA-Targeting CAR T-Cell Therapy
The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
45
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-post: global-roche-genentech-trials@gene.com
Studer Kontakt Backup
- Navn: Fastest Response:use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studiesteder
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Jena, Tyskland, 07747
- Rekruttering
- Universitätsklinikum Jena, Klinik für Innere Medizin II
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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
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to the start of administration of study treatment.
- Received one to four lines of prior therapy, including prior B-cell maturation antigen (BCMA)-targeting Chimeric Antigen Receptors (CAR) T-cell therapy
- Multiple Myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Is triple-class exposed, i.e. received anti- cluster of differentiation 38 (CD38) therapy, a proteasome inhibitor (PI) and lenalidomide in any prior line
- Participants must have measurable disease during screening
Exclusion Criteria:
- Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
- Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/µL or 5% of the peripheral blood white cells
- History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or known hypersensitivity to any of the excipients of cevostamab
- Gastrointestinal (GI) disease that might significantly alter absorption of oral drugs
- Known active Central Nervous System (CNS) involvement, or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole-brain MRI and lumbar cytology are required.
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 |
|---|---|
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Eksperimentell: Cevostamab plus Pomalidomide and Dexamethasone (Pd)
Cevostamab will be combined with pomalidomide and dexamethasone as the experimental treatment in this study.
Participants will receive Cevostamab as per the schedule in the protocol.
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Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Andre navn:
Participants will receive cevostamab as per the schedule given in the protocol.
Andre navn:
Pomalidomide will be administered as per the schedule given in the protocol.
Dexamethasone will be administered as a premedication as per the schedule given in the protocol.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Overall Response Rate (ORR) as assessed by an Independent Review Committee
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Varighet av respons (DOR)
Tidsramme: Opptil ca 3 år
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Opptil ca 3 år
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ORR, as assessed by the Investigator
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
|
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Rate of Very Good Partial Response (VGPR) or Better
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
|
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Complete Response/Stringent Complete Response (CR/sCR) Rate
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
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Progression-free Survival (PFS)
Tidsramme: Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years)
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Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years)
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Overall Survival (OS)
Tidsramme: Baseline up until death from any cause (up to approximately 3 years)
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Baseline up until death from any cause (up to approximately 3 years)
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MRD-negative CR rate at 9 months measured in bone marrow aspirate by next-generation sequencing (NGS)
Tidsramme: At 9 months
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At 9 months
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Overall MRD-Negative Complete Response Rate
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Time to Response (TTR)
Tidsramme: Baseline up to approximately 3 years
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Baseline up to approximately 3 years
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Time to Better Response (TTBR)
Tidsramme: Baseline up to approximately 3 years
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Baseline up to approximately 3 years
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Progression-Free Survival 2 (PFS2)
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
|
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Time to Confirmed Deterioration in the Disease Symptoms Scale of the EORTC QLQ-MY20
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
|
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Time to Confirmed Deterioration in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30)
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Incidence and Severity of Adverse Events (AEs)
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
|
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Change From Baseline in the Disease Symptoms Scale of the EORTC QLQ-MY20
Tidsramme: Baseline and up to 3 years
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Baseline and up to 3 years
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Change From Baseline in the GHS/QoL of the EORTC QLQ-Core 30 (C30)
Tidsramme: Baseline and up to 3 years
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Baseline and up to 3 years
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Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30
Tidsramme: Baseline and up to 3 years
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Baseline and up to 3 years
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Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline
Tidsramme: Baseline
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Baseline
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Percentage of Participants with ADAs to Cevostamab during the Study
Tidsramme: Up to approximately 3 years
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Up to approximately 3 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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 (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
13. april 2029
Studiet fullført (Antatt)
30. januar 2031
Datoer for studieregistrering
Først innsendt
14. september 2026
Først innsendt som oppfylte QC-kriteriene
14. september 2026
Først lagt ut (Faktiske)
17. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, plasmacelle
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Hemoragiske lidelser
- Hemic og lymfatiske sykdommer
- Multippelt myelom
- Polysykliske forbindelser
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Steroider, fluorert
- Gravadienetrioler
- Deksametason
- tocilizumab
- pomalidomid
Andre studie-ID-numre
- CO46577
- 2026-525736-42-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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