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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

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

      • Jena, Tyskland, 07747
        • Rekruttering
        • Universitätsklinikum Jena, Klinik für Innere Medizin II

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
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.
Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Andre navn:
  • Actemra/RoActemra
Participants will receive cevostamab as per the schedule given in the protocol.
Andre navn:
  • RO7187797
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Overall Response Rate (ORR) as assessed by an Independent Review Committee
Tidsramme: Up to approximately 3 years
Up to approximately 3 years

Sekundære resultatmål

Resultatmål
Tidsramme
Varighet av respons (DOR)
Tidsramme: Opptil ca 3 år
Opptil ca 3 år
ORR, as assessed by the Investigator
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Rate of Very Good Partial Response (VGPR) or Better
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Complete Response/Stringent Complete Response (CR/sCR) Rate
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
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)
Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years)
Overall Survival (OS)
Tidsramme: Baseline up until death from any cause (up to approximately 3 years)
Baseline up until death from any cause (up to approximately 3 years)
MRD-negative CR rate at 9 months measured in bone marrow aspirate by next-generation sequencing (NGS)
Tidsramme: At 9 months
At 9 months
Overall MRD-Negative Complete Response Rate
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Time to Response (TTR)
Tidsramme: Baseline up to approximately 3 years
Baseline up to approximately 3 years
Time to Better Response (TTBR)
Tidsramme: Baseline up to approximately 3 years
Baseline up to approximately 3 years
Progression-Free Survival 2 (PFS2)
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Time to Confirmed Deterioration in the Disease Symptoms Scale of the EORTC QLQ-MY20
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
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
Up to approximately 3 years
Incidence and Severity of Adverse Events (AEs)
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Change From Baseline in the Disease Symptoms Scale of the EORTC QLQ-MY20
Tidsramme: Baseline and up to 3 years
Baseline and up to 3 years
Change From Baseline in the GHS/QoL of the EORTC QLQ-Core 30 (C30)
Tidsramme: Baseline and up to 3 years
Baseline and up to 3 years
Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30
Tidsramme: Baseline and up to 3 years
Baseline and up to 3 years
Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline
Tidsramme: Baseline
Baseline
Percentage of Participants with ADAs to Cevostamab during the Study
Tidsramme: Up to approximately 3 years
Up to approximately 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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

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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