Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy
Hoffmann-La Roche
380 participants
Jun 30, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
Participants will receive cevostamab IV as per the schedule given in the protocol.
Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.
Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.
Participants will receive daratumumab SC as per the schedule given in the protocol.
Participants will receive elotuzumab IV as per the schedule given in the protocol.
Participants will receive carfilzomib IV as per the schedule given in the protocol.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07555938