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NCT Number: NCT07825064

Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum Jena, Klinik für Innere Medizin II

Jena, 07747, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cevostamab

Drug

Participants will receive cevostamab as per the schedule given in the protocol.

Other names: RO7187797

Pomalidomide

Drug

Pomalidomide will be administered as per the schedule given in the protocol.

Dexamethasone

Drug

Dexamethasone will be administered as a premedication as per the schedule given in the protocol.

Tocilizumab

Drug

Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Other names: Actemra/RoActemra

Primary outcomes

  1. Overall Response Rate (ORR) as assessed by an Independent Review Committee

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. ORR, as assessed by the Investigator

    Time frame: Up to approximately 3 years

  2. Rate of Very Good Partial Response (VGPR) or Better

    Time frame: Up to approximately 3 years

  3. Complete Response/Stringent Complete Response (CR/sCR) Rate

    Time frame: Up to approximately 3 years

  4. Duration of Response (DOR)

    Time frame: Up to approximately 3 years

  5. Progression-free Survival (PFS)

    Time frame: Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years)

  6. Overall Survival (OS)

    Time frame: Baseline up until death from any cause (up to approximately 3 years)

  7. MRD-negative CR rate at 9 months measured in bone marrow aspirate by next-generation sequencing (NGS)

    Time frame: At 9 months

  8. Overall MRD-Negative Complete Response Rate

    Time frame: Up to approximately 3 years

  9. Time to Response (TTR)

    Time frame: Baseline up to approximately 3 years

  10. Time to Better Response (TTBR)

    Time frame: Baseline up to approximately 3 years

  11. Progression-Free Survival 2 (PFS2)

    Time frame: Up to approximately 3 years

  12. Time to Confirmed Deterioration in the Disease Symptoms Scale of the EORTC QLQ-MY20

    Time frame: Up to approximately 3 years

  13. Time to Confirmed Deterioration in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30)

    Time frame: Up to approximately 3 years

  14. Incidence and Severity of Adverse Events (AEs)

    Time frame: Up to approximately 3 years

  15. Change From Baseline in the Disease Symptoms Scale of the EORTC QLQ-MY20

    Time frame: Baseline and up to 3 years

  16. Change From Baseline in the GHS/QoL of the EORTC QLQ-Core 30 (C30)

    Time frame: Baseline and up to 3 years

  17. Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30

    Time frame: Baseline and up to 3 years

  18. Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30

    Time frame: Up to approximately 3 years

  19. Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20

    Time frame: Up to approximately 3 years

  20. Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30

    Time frame: Up to approximately 3 years

  21. Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30

    Time frame: Up to approximately 3 years

  22. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline

    Time frame: Baseline

  23. Percentage of Participants with ADAs to Cevostamab during the Study

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest Response:use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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