Actively Recruiting
A Phase 1b/2 Study to Evaluate the Safety and Efficacy of Sonrotoclax Alone and Combined With Dexamethasone, Carfilzomib, Daratumumab, or Pomalidomide in Relapsed/Refractory Multiple Myeloma With t(11;14)
Led by BeOne Medicines · Updated on 2026-05-11
246
Participants Needed
84
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of sonrotoclax alone and in combination with dexamethasone, carfilzomib, daratumumab, and pomalidomide in patients with relapsed or refractory multiple myeloma who have a specific chromosomal change called t(11;14). This Phase 1b/2 study is sponsored by BeOne Medicines and aims to find the best dose and treatment combinations for these patients. The study includes a dose-escalation phase to find the maximum tolerated dose of sonrotoclax combined with dexamethasone and other drugs. There are up to seven expansion cohorts to further test sonrotoclax alone and with combinations of dexamethasone plus carfilzomib, daratumumab, or pomalidomide. Sonrotoclax is taken orally daily, dexamethasone is given once weekly by mouth or intravenously, carfilzomib is given intravenously weekly, daratumumab is given subcutaneously weekly, and pomalidomide is taken orally daily. Participants will be monitored closely with safety assessments including dose-limiting toxicities and adverse events. Effectiveness will be measured by response rates and disease progression over about four years. Blood samples and other tests will track how the drugs behave in the body and patient outcomes. Treatment responses, progression-free survival, and overall survival are key outcomes. The study started in September 2021 and is expected to continue until November 2026.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Confirmed diagnosis of multiple myeloma with M-component in serum and/or urine
- Measurable disease defined by M-spike ≥ 500 mg/dL, or urine protein M-spike ≥ 200 mg/day, or serum free light chains ≥ 10 mg/dL with abnormal κ:λ ratio
- Documented relapsed or progressive multiple myeloma after prior treatment regimens
- Part 1 and Cohorts 1 and 2: Relapsed or progressive disease with ≥ 3 prior therapy lines including proteasome inhibitor, IMiD, and anti-CD38 monoclonal antibody, with no available approved therapies
- Cohorts 3, 4, and 5: Relapsed or progressive disease with ≥ 1 prior therapy line; prior carfilzomib allowed if not refractory
- Cohorts 6 and 7: Relapsed or progressive disease with 1 to 3 prior therapy lines including proteasome inhibitor and IMiD
- Confirmed positivity for t(11;14) translocation by validated FISH testing
- Adequate organ function including hemoglobin ≥ 8.0 g/dL, platelet count ≥ 75,000/μL, ANC ≥ 1000/mm³, ALT and AST ≤ 3 × ULN, total bilirubin ≤ 2.0 × ULN (or < 3 × ULN for Gilbert's syndrome)
You will not qualify if you...
- Non secretory multiple myeloma (serum free light chains < 10 mg/dL)
- Solitary plasmacytoma
- Active plasma cell leukemia
- Waldenström macroglobulinemia
- Amyloidosis
- POEMS syndrome
- Chronic respiratory disease requiring continuous oxygen
- Significant cardiovascular disease including recent myocardial infarction, ejection fraction ≤ 50%, unstable angina, severe heart failure, significant arrhythmias, prolonged QT interval, certain heart blocks, or uncontrolled hypertension
- Prior therapy with sonrotoclax or other BCL2 inhibitors
- Known HIV infection
- Active hepatitis B or C infection as defined by specific serologic criteria
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive daily oral sonrotoclax alone or combined with weekly dexamethasone and either weekly carfilzomib, weekly daratumumab, or daily pomalidomide to treat multiple myeloma.
Weekly visits during treatment cycles
Duration - Up to 30 days after last dose
Participants are monitored for safety and treatment response after stopping study drug.
1 to 2 visits after treatment ends
Trial Site Locations
Total: 84 locations
1
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States, 35294-0004
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010-3012
Actively Recruiting
3
City of Hope Irvine Lennar
Irvine, California, United States, 92618-2377
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136-2107
Actively Recruiting
5
Emory University Winship Cancer Center
Atlanta, Georgia, United States, 30322-1013
Actively Recruiting
6
University of Chicago Medical Center
Chicago, Illinois, United States, 60637-1443
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Completed
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
9
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601-1915
Actively Recruiting
10
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, United States, 10065-4870
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States, 10065-6800
Actively Recruiting
12
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, United States, 43210-1240
Actively Recruiting
13
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
Actively Recruiting
14
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
15
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792-0001
Actively Recruiting
16
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226-1222
Actively Recruiting
17
Canberra Hospital
Garran, Australian Capital Territory, Australia, ACT 2605
Actively Recruiting
18
Nepean Hospital
Kingswood, New South Wales, Australia, NSW 2747
Actively Recruiting
19
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
20
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, VIC 3065
Actively Recruiting
21
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
22
Royal Perth Hospital
Perth, Western Australia, Australia, WA 6000
Actively Recruiting
23
Hospital Sirio Libanes Brasilia
Brasília, Brazil, 70200-730
Actively Recruiting
24
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, Brazil, 70390140
Actively Recruiting
25
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil, 90110-270
Actively Recruiting
26
Hospital Sao Rafael (Rede Dor)
Salvador, Brazil, 41253-190
Actively Recruiting
27
Hospital Sirio Libanes
São Paulo, Brazil, 01308-050
Actively Recruiting
28
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil, 01401-004
Actively Recruiting
29
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil, 05652-900
Actively Recruiting
30
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
31
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
32
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
33
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
34
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
35
Peking University Peoples Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
36
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
37
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Completed
38
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Completed
39
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
40
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Completed
41
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
42
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
43
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
44
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
45
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Completed
46
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
47
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
48
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China, 332000
Actively Recruiting
49
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
50
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266000
Actively Recruiting
51
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
52
Shanghai Fourth Peoples Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China, 200434
Completed
53
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Completed
54
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China, 301617
Actively Recruiting
55
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
56
Hopital Claude Huriez Chu Lille
Lille, France, 59000
Actively Recruiting
57
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France, 44000
Actively Recruiting
58
Chu de Poitiers Site de La Mileterie
Poitiers, France, 86000
Actively Recruiting
59
Universitaetsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
60
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, Germany, 01307
Actively Recruiting
61
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
62
Universitatsklinikum Wurzburg
Würzburg, Germany, 97080
Actively Recruiting
63
University Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
Actively Recruiting
64
General Hospital of Athens Alexandra
Athens, Greece, 115 28
Actively Recruiting
65
Azienda Ospedaliera Policlinico Di Bari
Bari, Italy, 70124
Actively Recruiting
66
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, Italy, 40138
Actively Recruiting
67
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, Italy, 47014
Actively Recruiting
68
Istituto Europeo Di Oncologia
Milan, Italy, 20141
Actively Recruiting
69
Istituto Di Candiolo Irccs
Torino, Italy, 10060
Actively Recruiting
70
Azienda Ospedaliera Universitaria Delle Marche
Torrette, Italy, 60020
Actively Recruiting
71
National University Hospital Singapore
Singapore, Singapore, 119074
Actively Recruiting
72
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
73
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
Actively Recruiting
74
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
75
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
76
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
77
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
78
Hospital San Pedro de Alcantara
Cáceres, Spain, 10002
Actively Recruiting
79
Hospital Universitario Virgen de La Victoria
Málaga, Spain, 29010
Actively Recruiting
80
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
81
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, United Kingdom, OX3 7LE
Actively Recruiting
82
University College Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
83
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
84
Royal Cornwall Hospitalsnhs Trust
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
Research Team
B
BeOne Medicines
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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