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
| Registry | NCT07825064 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 45 (Estimated) |
| Sponsor | Hoffmann-La Roche (Industry) |
| Conditions | Multiple Myeloma |
| Interventions | Cevostamab, Pomalidomide, Dexamethasone, Tocilizumab (Drug) |
| Dates | start 2026-10-30 (estimated), primary completion 2029-04-13 (estimated), completion 2031-01-19 (estimated), first posted 2026-09-17, last updated 2026-10-15 |
| Locations | 2 sites in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Myeloma All trials of Cevostamab All trials of Pomalidomide
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cevostamab plus Pomalidomide and Dexamethasone (Pd) | Experimental | Drug: Cevostamab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Tocilizumab | 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. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Universitätsmedizin Greifswald | Greifswald | Germany | Recruiting |
| Universitätsklinikum Jena, Klinik für Innere Medizin II | Jena | Germany | Recruiting |