RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07825064

Registry updated: 2026-10-15

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Description

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.

Interventions

Cevostamab (Drug)
Participants will receive cevostamab as per the schedule given in the protocol.
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.

Eligibility criteria

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.

Conditions

Multiple Myeloma

Locations

Universitätsmedizin Greifswald — Greifswald, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II — Jena, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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