- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
45
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: 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
Studera Kontakt Backup
- Namn: Fastest Response:use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studieorter
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Jena, Tyskland, 07747
- Rekrytering
- Universitätsklinikum Jena, Klinik für Innere Medizin II
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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
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
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 |
|---|---|
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Experimentell: 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.
Andra namn:
Participants will receive cevostamab as per the schedule given in the protocol.
Andra namn:
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Overall Response Rate (ORR) as assessed by an Independent Review Committee
Tidsram: Up to approximately 3 years
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Up to approximately 3 years
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Duration of Response (DOR)
Tidsram: Upp till cirka 3 år
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Upp till cirka 3 år
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ORR, as assessed by the Investigator
Tidsram: 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
Tidsram: 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
Tidsram: Up to approximately 3 years
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Up to approximately 3 years
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Progression-free Survival (PFS)
Tidsram: 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)
Tidsram: 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)
Tidsram: At 9 months
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At 9 months
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Overall MRD-Negative Complete Response Rate
Tidsram: Up to approximately 3 years
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Up to approximately 3 years
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Time to Response (TTR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
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Baseline
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Percentage of Participants with ADAs to Cevostamab during the Study
Tidsram: Up to approximately 3 years
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Up to approximately 3 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
13 april 2029
Avslutad studie (Beräknad)
30 januari 2031
Studieregistreringsdatum
Först inskickad
14 september 2026
Först inskickad som uppfyllde QC-kriterierna
14 september 2026
Första postat (Faktisk)
17 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Neoplasmer
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Hematologiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Neoplasmer, Plasmacell
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Hemorragiska störningar
- Hemiska och lymfsjukdomar
- Multipelt myelom
- Polycykliska föreningar
- Graviditet
- Graviditet
- Steroider
- Fusion-ringföreningar
- Steroider, fluorerade
- Graviditet
- Dexametason
- tocilizumab
- pomalidomid
Andra studie-ID-nummer
- CO46577
- 2026-525736-42-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .