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

NCT07555938 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CO460962025-524028-23-002025
• Study Type: interventional
• Target: 380
• Locations: 16 countries
• Sites: 75

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (27)

• Very Good Partial Response (VGPR) or Better Rate

  Up to 5 years after the last participant is randomized

• Overall Survival (OS)

  Up to 5 years after the last participant is randomized

• Time to Confirmed Deterioration in the Disease Symptoms Scale as Assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Multiple Myeloma Module 20 (MY20)

  Up to 5 years after the last participant is randomized

• Overall Response Rate (ORR)

  Up to 5 years after the last participant is randomized

• Complete Response (CR) Rate

  Up to 5 years after the last participant is randomized

Study Arms (2)

Cevostamab + Pomalidomide + Dexamethasone

EXPERIMENTAL

Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards. Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards. Dexamethasone will be administered as a premedication prior to cevostamab.

Drug: Cevostamab; Drug: Pomalidomide; Drug: Dexamethasone

Standard of Care (SOC)

ACTIVE COMPARATOR

Participants will receive investigator's choice of one SOC regimen.

Drug: Pomalidomide; Drug: Dexamethasone; Drug: Daratumumab; Drug: Elotuzumab; Drug: Carfilzomib

Interventions

Cevostamab DRUG

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

Cevostamab + Pomalidomide + Dexamethasone

Pomalidomide DRUG

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

Cevostamab + Pomalidomide + Dexamethasone; Standard of Care (SOC)

Dexamethasone DRUG

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

Cevostamab + Pomalidomide + Dexamethasone; Standard of Care (SOC)

Daratumumab DRUG

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

Standard of Care (SOC)

Elotuzumab DRUG

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

Standard of Care (SOC)

Carfilzomib DRUG

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

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (75)

City of Hope National Medical Center

Duarte, California, 91010-3012, United States

RECRUITING

City of Hope - Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

MedStar Washington Hospital Center MedStar Georgetown Cancer Institute

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Novant Health Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

Winston-Salem, North Carolina, 27103, United States

RECRUITING

TriHealth Cancer and Blood Institute

Cincinnati, Ohio, 45220, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-000, Brazil

RECRUITING

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510555, China

RECRUITING

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

Nanjing, Jiangsu, 210008, China

RECRUITING

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

The First Affilliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

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

Hangzhou, Zhejiang, 310003, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, 510515, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, 250012, China

RECRUITING

The First Affiliate Hospital of Guangxi Medical University

Nanning, 530021, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, 200032, China

RECRUITING

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325035, China

RECRUITING

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

RECRUITING

Fakultni nemocnice Ostrava

Ostrava, 708 52, Czechia

RECRUITING

Aarhus Universitetshospital

Aarhus, 8000, Denmark

RECRUITING

Sygehus Lillebælt, Vejle;Hæmatologisk Forskningsenhed, HKFE

Vejle, 7100, Denmark

RECRUITING

HELIOS Klinikum Bad Saarow

Bad Saarow, 15526, Germany

RECRUITING

Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

Berlin, 10967, Germany

RECRUITING

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, 12200, Germany

RECRUITING

Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin

Düsseldorf, 40479, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

RECRUITING

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

RECRUITING

UKSH, Campus Kiel

Kiel, 24105, Germany

RECRUITING

Evangelismos General Hospital of Athens

Athens, 106 76, Greece

RECRUITING

Alexandras General Hospital of Athens

Athens, 11528, Greece

RECRUITING

Anticancer Hospital of Thessaloniki " Theagenio"

Thessaloniki, 540 07, Greece

RECRUITING

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

Hadassah Ein Karem Hospital

Jerusalem, 9112001, Israel

RECRUITING

Chaim Sheba Medical Center

Ramat Gan, 5266200, Israel

RECRUITING

Ichilov Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

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

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

Asst Papa Giovanni Xxiii

Bergamo, Lombardy, 24127, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

RECRUITING

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, 441-8570, Japan

RECRUITING

Nagoya City University Hospital

Aichi, 467-8602, Japan

RECRUITING

Matsuyama Red Cross Hospital

Ehime, 790-8524, Japan

RECRUITING

Gunma University Hospital

Gunma, 371-8511, Japan

RECRUITING

Hyogo Medical University Hospital

Hyōgo, 663-8501, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

Iwate Medical University Hospital

Numakunai, 028-3695, Japan

RECRUITING

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

RECRUITING

Osaka University Hospital

Osaka, 565-0871, Japan

RECRUITING

Dokkyo Medical University Saitama Medical Center

Saitama, 343-8555, Japan

RECRUITING

Japanese Red Cross Medical Center

Shibuya-ku, 150-8935, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

Yamagata University Hospital

Yamagata, 990-9585, Japan

RECRUITING

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

Krakow, Lesser Poland Voivodeship, 30-688, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland

RECRUITING

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

Warsaw, 02-721, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroc?aw, 50-367, Poland

RECRUITING

Auxilio Mutuo Cancer Center

San Juan, 917, Puerto Rico

RECRUITING

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Seoul St Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Hospital Costa del Sol

Marbella, Malaga, 29603, Spain

RECRUITING

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Related Links

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide; Dexamethasone; daratumumab; elotuzumab; carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): January 31, 2033
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (2); CN (13); AU (1); BR (1); CZ (2); US (9); PR (1); JP (13); KR (6); PL (4); DE (7); IL (4); IT (3); ES (5); CA (1); GR (3)