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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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)

NCT04973605•BeOne Medicines

View on ClinicalTrials.gov

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.

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

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
+9 more criteria

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 California At San Francisco

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Emory University Winship Cancer Center

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

September 16, 2021

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

March 19, 2026

Enrollment

246

ESTIMATED participants

Conditions

Relapsed/Refractory Multiple Myeloma

Interventions

Sonrotoclax

DRUG

Dexamethasone

DRUG

Carfilzomib

DRUG

Daratumumab

DRUG

Pomalidomide

DRUG

Contacts

BeOne Medicines

CONTACT

1.877.828.5568 clinicaltrials@beonemed.com

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

NCT05862012

Relapsed/Refractory Multiple Myeloma

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RECRUITINGPHASE2

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT07284758

Multiple MyelomaRelapsed/Refractory Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

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