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Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

RECRUITINGPhase 3Sponsored by Hoffmann-La Roche
Actively Recruiting
PhasePhase 3
SponsorHoffmann-La Roche
Started2026-06-30
Est. completion2028-10-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerMultiple Myeloma

Interventions6

Locations3 sites

California

2 sites
City of Hope National Medical Center
Duarte, California, 91010-3012
City of Hope - Lennar Foundation Cancer Center
Irvine, California, 92618

Georgia

1 site
Winship Cancer Institute of Emory University

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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