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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

Interested in This Trial?

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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

Yale University

New Haven, Connecticut 06510

United States

MedStar Washington Hospital Center MedStar Georgetown Cancer Institute

Washington D.C., District of Columbia 20010

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Novant Health Cancer Institute

Charlotte, North Carolina 28215

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

MD Anderson Cancer Center

Houston, Texas 77030-4009

United States

West Virginia University

Morgantown, West Virginia 26506

United States

St Vincent's Hospital Melbourne

Fitzroy, Victoria 3065

Australia

The Alfred Hospital

Melbourne, Victoria 3004

Australia

Hospital Israelita Albert Einstein

São Paulo, São Paulo 05652-000

Brazil

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario L8V 1C3

Canada

Sun yat-sen University Cancer Center

Guangzhou, Guangdong 510555

China

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu 210008

China

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong 266003

China

Tianjin Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality 301636

China

The First Affilliated Hospital of Kunming Medical University

Kunming, Yunnan 650032

China

The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS

Hangzhou, Zhejiang 310003

China

Nanfang Hospital, Southern Medical University

Guangzhou, 510515

China

Qilu Hospital of Shandong University

Jinan, 250012

China

The First Affiliate Hospital of Guangxi Medical University

Nanning, 530021

China

Zhongshan Hospital Fudan University

Shanghai, 200032

China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200127

China

The First Affiliated Hospital of Soochow University

Suzhou, 215006

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325035

China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030

China

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni nemocnice Ostrava

Ostrava, 708 52

Czechia

Aarhus Universitetshospital

Aarhus, 8000

Denmark

Rigshospitalet

København Ø, 2100

Denmark

Sygehus Lillebælt, Vejle;Hæmatologisk Forskningsenhed, HKFE

Vejle, 7100

Denmark

CHU de Nantes - Hôtel-Dieu

Nantes, Loire-Atlantique 44093

France

CHRU de Lille - Hopital Claude Huriez

Lille, 59037

France

CHU Lyon - Centre Hospitalier Lyon Sud

Pierre-Benite (Lyon), 69495

France

CHU de Poitiers - La Miletrie

Poitiers, 86021

France

CHU de Toulouse -Service d'Hématologie

Toulouse, 31100

France

HELIOS Klinikum Bad Saarow

Bad Saarow, 15526

Germany

Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

Berlin, 10967

Germany

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, 12200

Germany

Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin

Düsseldorf, 40479

Germany

Universitätsklinikum Frankfurt

Frankfurt, 60590

Germany

Universitätsmedizin Greifswald

Greifswald, 17475

Germany

UKSH, Campus Kiel

Kiel, 24105

Germany

Evangelismos General Hospital of Athens

Athens, 106 76

Greece

Alexandras General Hospital of Athens

Athens, 11528

Greece

Anticancer Hospital of Thessaloniki " Theagenio"

Thessaloniki, 540 07

Greece

Rambam Health Care Campus

Haifa, 31096

Israel

Hadassah Ein Karem Hospital

Jerusalem, 9112001

Israel

Chaim Sheba Medical Center

Ramat Gan, 5266200

Israel

Ichilov Sourasky Medical Center

Tel Aviv, 6423906

Israel

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna 40138

Italy

IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

Meldola, Emilia-Romagna 47014

Italy

Asst Papa Giovanni Xxiii

Bergamo, Lombardy 24127

Italy

Istituto Clinico Humanitas

Rozzano, Lombardy 20089

Italy

AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette

Turin, Piedmont 10126

Italy

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken 441-8570

Japan

Nagoya City University Hospital

Aichi, 467-8602

Japan

Matsuyama Red Cross Hospital

Ehime, 790-8524

Japan

Gunma University Hospital

Gunma, 371-8511

Japan

Hyogo Medical University Hospital

Hyōgo, 663-8501

Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566

Japan

Iwate Medical University Hospital

Numakunai, 028-3695

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Osaka University Hospital

Osaka, 565-0871

Japan

Dokkyo Medical University Saitama Medical Center

Saitama, 343-8555

Japan

Japanese Red Cross Medical Center

Shibuya-ku, 150-8935

Japan

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

SP ZOZ Szpital Uniwersytecki w Krakowie-Jakubowskiego 2;Oddzial Kliniczny Hematologii

Krakow, Lesser Poland Voivodeship 30-688

Poland

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, 60-569

Poland

SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

Szczecin, 71-252

Poland

Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

Warsaw, 02-721

Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroc?aw, 50-367

Poland

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

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Seoul St Mary's Hospital

Seoul, 06591

South Korea

Institut Catala d?Oncologia Hospital Germans Trias i Pujol

Badalona, Barcelona 08916

Spain

Hospital Costa del Sol

Marbella, Malaga 29603

Spain

Clinica Universitaria de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28009

Spain

Hospital Clinico Universitario de Salamanca

Salamanca, 37007

Spain

University College London Hospitals NHS Foundation Trust

London, W1T 7HA

United Kingdom

Oxford Churchill Hospital

Oxford, OX3 7LE

United Kingdom

The Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, WV10 0QP

United Kingdom