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Clinical Trials in the USA / NCT04973605
Recruiting Phase 1/Phase 2

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

NCT04973605 · tracked via the Priya Life Science USA tracker
Sponsor
BeOne Medicines
Phase
Phase 1/Phase 2
Started
2021-09-16
Last updated
2026-09-14

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

SonrotoclaxDexamethasoneCarfilzomibDaratumumabPomalidomide

Sonrotoclax: Administered orally daily

Dexamethasone: Once weekly either orally or intravenously

Carfilzomib: Administered intravenously weekly

Daratumumab: Administered subcutaneously weekly

Pomalidomide: Administered orally daily

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
University of Alabama At Birmingham Hospital Birmingham Alabama Recruiting
City of Hope National Medical Center Duarte California Recruiting
City of Hope Irvine Lennar Irvine California Recruiting
University of Miami Miami Florida Recruiting
Emory University Winship Cancer Center Atlanta Georgia Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Massachusetts General Hospital Boston Massachusetts Completed
Washington University School of Medicine St Louis Missouri Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital New York New York Recruiting
Memorial Sloan Kettering Cancer Center Mskcc New York New York Recruiting
The James Cancer Hospital and Solove Research Institute At Ohio State University Columbus Ohio Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
University of Washington Seattle Washington Recruiting
University of Wisconsin Carbone Cancer Center Madison Wisconsin Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Canberra Hospital Garran Australian Capital Territory Recruiting
Nepean Hospital Kingswood New South Wales Recruiting
Monash Health Clayton Victoria Recruiting
St Vincents Hospital Melbourne Fitzroy Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Royal Perth Hospital Perth Western 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 Recruiting
British Columbia Cancer Agency the Vancouver Centre Vancouver British Columbia Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
Beijing Chao Yang Hospital Beijing Beijing Municipality Recruiting
Peking University Peoples Hospital Beijing Beijing Municipality Recruiting
Chongqing Cancer Hospital Chongqing Chongqing Municipality Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Completed
The First Affiliated Hospital of Xiamen University Xiamen Fujian Completed
Sun Yat Sen University Cancer Center Guangzhou Guangdong Recruiting
The Second Hospital of Hebei Medical University Shijiazhuang Hebei Completed

+ 38 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04973605 on ClinicalTrials.gov ↗ ← All trials in the USA