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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07555938

Registry updated: 2026-10-13
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Description

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.

Interventions

  • Cevostamab (Drug)
    Participants will receive cevostamab IV as per the schedule given in the protocol.
  • Pomalidomide (Drug)
    Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.
  • Dexamethasone (Drug)
    Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.
  • Daratumumab (Drug)
    Participants will receive daratumumab SC as per the schedule given in the protocol.
  • Elotuzumab (Drug)
    Participants will receive elotuzumab IV as per the schedule given in the protocol.
  • Carfilzomib (Drug)
    Participants will receive carfilzomib IV as per the schedule given in the protocol.

Eligibility criteria

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

Conditions

Multiple Myeloma

Locations

  • City of Hope National Medical Center — Duarte, California, United States
  • City of Hope - Lennar Foundation Cancer Center — Irvine, California, United States
  • Yale University — New Haven, Connecticut, United States
  • MedStar Washington Hospital Center MedStar Georgetown Cancer Institute — Washington D.C., District of Columbia, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Novant Health Cancer Institute — Charlotte, North Carolina, United States
  • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists — Winston-Salem, North Carolina, United States
  • TriHealth Cancer and Blood Institute — Cincinnati, Ohio, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • West Virginia University — Morgantown, West Virginia, United States
  • St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
  • The Alfred Hospital — Melbourne, Victoria, Australia
  • Hospital Israelita Albert Einstein — São Paulo, São Paulo, Brazil
  • Hamilton Health Sciences - Juravinski Cancer Centre — Hamilton, Ontario, Canada
  • Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China
  • The Affiliated Hospital Of Qingdao University — Qingdao, Shandong, China
  • Tianjin Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China
  • The First Affilliated Hospital of Kunming Medical University — Kunming, Yunnan, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS — Hangzhou, Zhejiang, China
  • Nanfang Hospital, Southern Medical University — Guangzhou, China
  • Qilu Hospital of Shandong University — Jinan, China
  • The First Affiliate Hospital of Guangxi Medical University — Nanning, China
  • Zhongshan Hospital Fudan University — Shanghai, China
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China
  • The First Affiliated Hospital of Soochow University — Suzhou, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
  • Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
  • Fakultni nemocnice Ostrava — Ostrava, Czechia
  • Aarhus Universitetshospital — Aarhus, Denmark
  • Rigshospitalet — København Ø, Denmark
  • Sygehus Lillebælt, Vejle;Hæmatologisk Forskningsenhed, HKFE — Vejle, Denmark
  • CHU de Nantes - Hôtel-Dieu — Nantes, Loire-Atlantique, France
  • CHRU de Lille - Hopital Claude Huriez — Lille, France
  • CHU Lyon - Centre Hospitalier Lyon Sud — Pierre-Benite (Lyon), France
  • CHU de Poitiers - La Miletrie — Poitiers, France
  • CHU de Toulouse -Service d'Hématologie — Toulouse, France
  • HELIOS Klinikum Bad Saarow — Bad Saarow, Germany
  • Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie — Berlin, Germany
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin — Berlin, Germany
  • Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin — Düsseldorf, Germany
  • Universitätsklinikum Frankfurt — Frankfurt, Germany
  • Universitätsmedizin Greifswald — Greifswald, Germany
  • UKSH, Campus Kiel — Kiel, Germany
  • Evangelismos General Hospital of Athens — Athens, Greece
  • Alexandras General Hospital of Athens — Athens, Greece
  • Anticancer Hospital of Thessaloniki " Theagenio" — Thessaloniki, Greece
  • Rambam Health Care Campus — Haifa, Israel
  • Hadassah Ein Karem Hospital — Jerusalem, Israel
  • Chaim Sheba Medical Center — Ramat Gan, Israel
  • Ichilov Sourasky Medical Center — Tel Aviv, Israel
  • Policlinico S.Orsola-Malpighi — Bologna, Emilia-Romagna, Italy
  • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori" — Meldola, Emilia-Romagna, Italy
  • Asst Papa Giovanni Xxiii — Bergamo, Lombardy, Italy
  • Istituto Clinico Humanitas — Rozzano, Lombardy, Italy
  • AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette — Turin, Piedmont, Italy
  • Toyohashi Municipal Hospital — Toyohashi, Aichi-ken, Japan
  • Nagoya City University Hospital — Aichi, Japan
  • Matsuyama Red Cross Hospital — Ehime, Japan
  • Gunma University Hospital — Gunma, Japan
  • Hyogo Medical University Hospital — Hyōgo, Japan
  • University Hospital Kyoto Prefectural University of Medicine — Kyoto, Japan
  • Iwate Medical University Hospital — Numakunai, Japan
  • National Hospital Organization Okayama Medical Center — Okayama, Japan
  • Osaka University Hospital — Osaka, Japan
  • Dokkyo Medical University Saitama Medical Center — Saitama, Japan
  • Japanese Red Cross Medical Center — Shibuya-ku, Japan
  • The Cancer Institute Hospital of JFCR — Tokyo, Japan
  • Yamagata University Hospital — Yamagata, Japan
  • SP ZOZ Szpital Uniwersytecki w Krakowie-Jakubowskiego 2;Oddzial Kliniczny Hematologii — Krakow, Lesser Poland Voivodeship, Poland
  • Uniwersyteckie Centrum Kliniczne — Gda?sk, Poland
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Późna, Poland
  • SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego — Szczecin, Poland
  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy — Warsaw, Poland
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroc?aw, Poland
  • Auxilio Mutuo Cancer Center — San Juan, Puerto Rico
  • Chonnam National University Hwasun Hospital — Jeollanam-do, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Seoul St Mary's Hospital — Seoul, South Korea
  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
  • Hospital Costa del Sol — Marbella, Malaga, Spain
  • Clinica Universitaria de Navarra — Pamplona, Navarre, Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • Hospital Clinic i Provincial de Barcelona — Barcelona, Spain
  • Hospital General Universitario Gregorio Marañon — Madrid, Spain
  • Hospital Clinico Universitario de Salamanca — Salamanca, Spain
  • University College London Hospitals NHS Foundation Trust — London, United Kingdom
  • Oxford Churchill Hospital — Oxford, United Kingdom
  • The Royal Wolverhampton Hospitals NHS Trust — Wolverhampton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record