Home › Trials › NCT04973605

Testing sonrotoclax alone and with other treatments for 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)

Phase1; Phase2 Interventional BeOne Medicines · NCT04973605

This study is testing a new treatment called sonrotoclax, alone and with other medications, to see if it helps people with a specific type of multiple myeloma that has come back or hasn’t responded to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment246 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionsdaratumumab
Locations84 sites (Birmingham, Alabama and 83 other locations)
Trial IDNCT04973605 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and efficacy of sonrotoclax as a standalone treatment and in combination with dexamethasone and other agents like carfilzomib, daratumumab, and pomalidomide in patients with relapsed or refractory multiple myeloma. It focuses on patients with a specific chromosomal translocation (t(11;14)) and aims to determine the effectiveness of these combinations in managing the disease. The study is conducted in two phases, allowing for a thorough assessment of the treatment's impact on patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults with relapsed or refractory multiple myeloma who have undergone at least three prior lines of therapy.

Not a fit: Patients who have not been diagnosed with multiple myeloma or those with early-stage disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar combination therapies in multiple myeloma, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.