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Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
Trial Status: active
The purpose of this study is to assess the efficacy and safety of cevostamab in
combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC)
in participants with multiple myeloma (MM) who have received one to three prior lines of
therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.
Inclusion Criteria
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.
Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide
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/liter (L) or 5% of the peripheral blood white cells
GI disease that might significantly alter absorption of oral drugs
Participants must not have any ongoing CNS disease or non-secretory myeloma
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07555938.