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

NCT07555938 · tracked via the Priya Life Science USA tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 3

Started

2026-06-23

Last updated

2026-09-11

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

CevostamabPomalidomideDexamethasoneDaratumumabElotuzumabCarfilzomib

Cevostamab: Participants will receive cevostamab IV as per the schedule given in the protocol.

Pomalidomide: Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.

Dexamethasone: Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.

Daratumumab: Participants will receive daratumumab SC as per the schedule given in the protocol.

Elotuzumab: Participants will receive elotuzumab IV as per the schedule given in the protocol.

Carfilzomib: Participants will receive carfilzomib IV as per the schedule given in the protocol.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate — Up to 1 year after the last participant is randomized
Progression-Free Survival (PFS) — Up to 5 years after the last participant is randomized

Trial sites (75)

Facility	City	Region	Status
City of Hope National Medical Center	Duarte	California	Recruiting
City of Hope - Lennar Foundation Cancer Center	Irvine	California	Recruiting
Yale University	New Haven	Connecticut	Recruiting
MedStar Washington Hospital Center MedStar Georgetown Cancer Institute	Washington D.C.	District of Columbia	Recruiting
Emory University Hospital Midtown	Atlanta	Georgia	Recruiting
Novant Health Cancer Institute	Charlotte	North Carolina	Recruiting
Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists	Winston-Salem	North Carolina	Recruiting
TriHealth Cancer and Blood Institute	Cincinnati	Ohio	Recruiting
West Virginia University	Morgantown	West Virginia	Recruiting
St Vincent's Hospital Melbourne	Fitzroy	Victoria	Recruiting
Hospital Israelita Albert Einstein	São Paulo	São Paulo	Recruiting
Hamilton Health Sciences - Juravinski Cancer Centre	Hamilton	Ontario	Recruiting
Sun yat-sen University Cancer Center	Guangzhou	Guangdong	Recruiting
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	Recruiting
The Affiliated Hospital Of Qingdao University	Qingdao	Shandong	Recruiting
The First Affilliated Hospital of Kunming Medical University	Kunming	Yunnan	Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS	Hangzhou	Zhejiang	Recruiting
Nanfang Hospital, Southern Medical University	Guangzhou	China	Recruiting
Qilu Hospital of Shandong University	Jinan	China	Recruiting
The First Affiliate Hospital of Guangxi Medical University	Nanning	China	Recruiting
Zhongshan Hospital Fudan University	Shanghai	China	Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	China	Recruiting
The First Affiliated Hospital of Soochow University	Suzhou	China	Recruiting
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	China	Recruiting
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	China	Recruiting
Fakultni nemocnice Hradec Kralove	Hradec Králové	Czechia	Recruiting
Fakultni nemocnice Ostrava	Ostrava	Czechia	Recruiting
Aarhus Universitetshospital	Aarhus	Denmark	Recruiting
Sygehus Lillebælt, Vejle;Hæmatologisk Forskningsenhed, HKFE	Vejle	Denmark	Recruiting
HELIOS Klinikum Bad Saarow	Bad Saarow	Germany	Recruiting
Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie	Berlin	Germany	Recruiting
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin	Berlin	Germany	Recruiting
Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin	Düsseldorf	Germany	Recruiting
Universitätsklinikum Frankfurt	Frankfurt	Germany	Recruiting
Universitätsmedizin Greifswald	Greifswald	Germany	Recruiting
UKSH, Campus Kiel	Kiel	Germany	Recruiting
Evangelismos General Hospital of Athens	Athens	Greece	Recruiting
Alexandras General Hospital of Athens	Athens	Greece	Recruiting
Anticancer Hospital of Thessaloniki " Theagenio"	Thessaloniki	Greece	Recruiting
Rambam Health Care Campus	Haifa	Israel	Recruiting

+ 35 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07555938 on ClinicalTrials.gov ↗ ← All trials in the USA