NCT04973605From ClinicalTrials.govRecruiting

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)

Relapsed/Refractory Multiple Myeloma

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: BeOne Medicines
Enrolment target: 246
Started: 16 September 2021
Main results due: November 2026
Study sites: 77
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
3. Measurable disease defined as:

i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
4. Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.

i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.

ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.
1. In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.
2. Participants in Part 2 Cohorts 3, 4, and 5 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.
3. Participants in Part 2 Cohorts 6 and 7 should have relapsed or progressive disease and have had 1 to 3 prior lines of therapy and previously treated with a proteasome inhibitor and an IMiD
5. Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory

a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
6. Adequate organ function defined as:

1. Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
2. Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
3. Absolute neutrophil count (ANC) ≥ 1000/mm\^3 within 7 days before first dose of study treatment
4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be \< 3 x ULN for patients with Gilbert's syndrome)

Exclusion Criteria:

1. Participant has any of the following conditions:

1. Non secretory MM (Serum free light chains \< 10 mg/dL)
2. Solitary plasmacytoma
3. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or \> 2.0 x 109/L circulating plasma cells by standard differential)
4. Waldenström macroglobulinemia (WM)
5. Amyloidosis.
6. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
7. Chronic respiratory disease that requires continuous oxygen
2. Significant cardiovascular disease, including but not limited to:

1. Myocardial infarction ≤ 6 months before screening
2. Ejection fraction ≤ 50%
3. Unstable angina≤ 3 months before screening
4. New York Heart Association Class III or IV congestive heart failure
5. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
6. Heart rate-corrected QT interval \> 480 milliseconds based on Fridericia's formula
7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
8. Uncontrolled hypertension at screening, defined as systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg by ≥ 2 consecutive measurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)
3. Known infection with human immunodeficiency virus (HIV)
4. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:

1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity \< 20 IU/mL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.
2. Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity \< 15 IU/mL).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(77)

University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Recruiting
City of Hope National Medical Center
Duarte, California, United States
Recruiting
City of Hope Irvine Lennar
Irvine, California, United States
Recruiting
University of Miami
Miami, Florida, United States
Recruiting
Emory University Winship Cancer Center
Atlanta, Georgia, United States
Recruiting
University of Chicago Medical Center
Chicago, Illinois, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Completed
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Recruiting
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, United States
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Recruiting
University of Washington
Seattle, Washington, United States
Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Recruiting
Canberra Hospital
Garran, Australian Capital Territory, Australia
Recruiting
Nepean Hospital
Kingswood, New South Wales, Australia
Recruiting
Monash Health
Clayton, Victoria, Australia
Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Royal Perth Hospital
Perth, Western Australia, Australia
Recruiting
Hospital Sirio Libanes Brasilia
Brasília, Brazil
Recruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, Brazil
Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Recruiting
Hospital Sao Rafael (Rede Dor)
Salvador, Brazil
Recruiting
Hospital Sirio Libanes
São Paulo, Brazil
Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Recruiting
Cross Cancer Institute
Edmonton, Alberta, Canada
Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, China
Recruiting
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
Recruiting
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Completed
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Completed
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Completed
Henan Cancer Hospital
Zhengzhou, Henan, China
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Active, not recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Recruiting
Hunan Cancer Hospital
Changsha, Hunan, China
Completed
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Recruiting
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China
Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, China
Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, China
Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Recruiting
Shanghai Fourth Peoples Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Completed
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Completed
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Recruiting
Hopital Claude Huriez Chu Lille
Lille, France
Recruiting
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France
Recruiting
Chu de Poitiers Site de La Mileterie
Poitiers, France
Completed
Universitaetsklinikum Aachen
Aachen, Germany
Recruiting
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, Germany
Recruiting
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany
Recruiting
Universitatsklinikum Wurzburg
Würzburg, Germany
Recruiting
University Hospital of Alexandroupolis
Alexandroupoli, Greece
Recruiting

Showing 60 of 77 sites — filter to narrow it down. 68 of the 77 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04973605. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me