Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT07555938
This study evaluates the efficacy and safety of CevosPd versus SOC in multiple myeloma patients with 1-3 prior therapies, including anti-CD38 mAb and lenalidomide. Eligible participants have an ECOG status of 0-2 and measurable disease. Interventions include cevostamab, pomalidomide, dexamethasone, daratumumab, elotuzumab, and carfilzomib, administered per protocol.
Patient Parameters
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Program Overview
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 Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 91010-3012 | Duarte | California |
| City of Hope - Lennar Foundation Cancer Center | 92618 | Irvine | California |
| Winship Cancer Institute of Emory University | 30329 | Atlanta | Georgia |
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