About this trial
This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 12 weeks
Agreement to provide bone marrow biopsy and aspirate samples
Resolution of adverse events from prior anti-cancer therapy to Grade <=1
Disqualifiers
Prior treatment with cevostamab or another agent targeting FcRH5
Inability to comply with protocol-mandated hospitalization and activities restrictions
Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable).
Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
Trial design
Treatments tested in this trial
- Cevostamab
- Tocilizumab
- Pomalidomide
- Daratumumab
- Dexamethasone
Treatment groups
Sponsors and collaborators
Genentech, Inc.
Lead sponsor
Hoffmann-La Roche
Collaborator