Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates the safety and activity of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in adults with multiple myeloma who have received 1–4 prior therapies and have been exposed to CD38 therapy, lenalidomide, a proteasome inhibitor, and BCMA-directed CAR T therapy. Participants receive the triplet plus tocilizumab as needed for cytokine-related events. The study will monitor responses, durability of response, and safety signals in a structured, multi-center setting. Eligibility requires measurable disease, ECOG 0–1, and prior triple-class exposure; key exclusions include amyloidosis, high circulating plasma cells, and severe allergic reactions. Lead sponsor is Hoffmann-La Roche with multiple European sites listed.

Why it matters

Who can join: the full rules

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.

Where it's running

• Klinikum Nürnberg Nord
  Nuremberg, Bavaria, Germany Recruiting
• Universitätsmedizin Greifswald
  Greifswald, Germany Recruiting
• UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V
  Heidelberg, Germany Recruiting
• Universitätsklinikum Jena, Klinik für Innere Medizin II
  Jena, Germany Recruiting
• UKSH, Campus Kiel
  Kiel, Germany Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.