RecruitingPhase 1Phase 2NCT04973605

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone/Carfilzomib, Dexamethasone/Daratumumab, and Dexamethasone/Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)

Sponsor

BeOne Medicines

Enrollment

246 participants

Start Date

Sep 16, 2021

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Multiple Myeloma

Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal translocation t(11;14). The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called sonrotoclax (BGB-11417) — either alone or combined with standard treatments — for people with multiple myeloma (a type of blood cancer) that has come back or is no longer responding to prior therapy. **You may be eligible if...** - You have a confirmed diagnosis of multiple myeloma with measurable levels in blood or urine - Your myeloma has relapsed (come back after a response) or is refractory (no longer responding to the most recent treatment) - You have adequate general health and performance status (ECOG 0–2) **You may NOT be eligible if...** - You have never received prior treatment for myeloma - Your myeloma cannot be measured by standard blood, urine, or protein tests - Your overall health or organ function is too poor to tolerate treatment - You have serious active infections or other significant medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSonrotoclax

Administered orally daily

DRUGDexamethasone

Once weekly either orally or intravenously

DRUGCarfilzomib

Administered intravenously weekly

DRUGDaratumumab

Administered subcutaneously weekly

DRUGPomalidomide

Administered orally daily

Locations(83)

University of Alabama At Birmingham Hospital

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope Irvine Lennar

Irvine, California, United States

University of Miami

Miami, Florida, United States

Emory University Winship Cancer Center

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Weill Cornell Medical College Newyork Presbyterian Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

The James Cancer Hospital and Solove Research Institute At Ohio State University

Columbus, Ohio, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Hospital Sirio Libanes Brasilia

Brasília, Brazil

Instituto Dor de Pesquisa E Ensino Distrito Federal

Brasília, Brazil

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Sao Rafael (Rede Dor)

Salvador, Brazil

Hospital Sirio Libanes

São Paulo, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Peking University Third Hospital

Beijing, Beijing Municipality, China

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

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

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Fourth Peoples Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hopital Claude Huriez Chu Lille

Lille, France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France

Chu de Poitiers Site de La Mileterie

Poitiers, France

Universitaetsklinikum Aachen

Aachen, Germany

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

University Hospital of Alexandroupolis

Alexandroupoli, Greece

General Hospital of Athens Alexandra

Athens, Greece

Azienda Ospedaliera Policlinico Di Bari

Bari, Italy

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

Meldola, Italy

Istituto Europeo Di Oncologia

Milan, Italy

Istituto Di Candiolo Irccs

Torino, Italy

Azienda Ospedaliera Universitaria Delle Marche

Torrette, Italy

National University Hospital Singapore

Singapore, Singapore

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitario Virgen de La Victoria

Málaga, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Oxford University Hospitals Nhs Trust Churchill Hospital

Headington, United Kingdom

University College Hospital

London, United Kingdom

Royal Marsden Nhs Foundation Royal Marsden Hospital

Sutton, United Kingdom

Royal Cornwall Hospitalsnhs Trust

Truro, United Kingdom

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NCT04973605

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