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NCT07555938PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

6/23/2026

Completion Date

1/31/2033

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Cevostamab

DRUG

Pomalidomide

DRUG

Dexamethasone

DRUG

Daratumumab

DRUG

Elotuzumab

DRUG

Carfilzomib

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Conditions

Multiple Myeloma

Locations

City of Hope National Medical Center

Duarte, California 91010-3012

United States

City of Hope - Lennar Foundation Cancer Center

Irvine, California 92618

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Novant Health Cancer Institute

Charlotte, North Carolina 28204

United States

Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

Winston-Salem, North Carolina 27103

United States

TriHealth Cancer and Blood Institute

Cincinnati, Ohio 45220

United States

Nagoya City University Hospital

Aichi, 467-8602

Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566

Japan

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

Auxilio Mutuo Cancer Center

San Juan, 917

Puerto Rico

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Seoul St Mary's Hospital

Seoul, 06591

South Korea