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Back|NCT04973605Recruiting
Official Title

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)

Phase
Phase 1/Phase 2
Sponsor
BeOne Medicines
Enrollment
246
Timeline
Sep 2021 → Nov 2026
About This Study

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 Criteria

Inclusion Criteria

  • 1Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • 2A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
  • 3Measurable disease defined as:
  • 4i. 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
  • 5Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
  • 6i. 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.
  • 7ii. 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.
  • 8In 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.
  • 9Participants 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.
  • 10Participants 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
  • 11Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory
  • 12a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
  • 13Adequate organ function defined as:
  • 14Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
  • 15Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
  • 16Absolute neutrophil count (ANC) ≥ 1000/mm\^3 within 7 days before first dose of study treatment
  • 17Alanine 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

  • 1Participant has any of the following conditions:
  • 2Non secretory MM (Serum free light chains \< 10 mg/dL)
  • 3Solitary plasmacytoma
  • 4Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or \> 2.0 x 109/L circulating plasma cells by standard differential)
  • 5Waldenström macroglobulinemia (WM)
  • 6Amyloidosis.
  • 7Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
  • 8Chronic respiratory disease that requires continuous oxygen
  • 9Significant cardiovascular disease, including but not limited to:
  • 10Myocardial infarction ≤ 6 months before screening
  • 11Ejection fraction ≤ 50%
  • 12Unstable angina≤ 3 months before screening
  • 13New York Heart Association Class III or IV congestive heart failure
  • 14History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  • 15Heart rate-corrected QT interval \> 480 milliseconds based on Fridericia's formula
  • 16History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
  • 17Uncontrolled 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)
  • 18Known infection with human immunodeficiency virus (HIV)
  • 19Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
  • 20Presence 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.
  • 21Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity \< 15 IU/mL).

Locations

85 sites participating in this study

Emory University Winship Cancer Center

Atlanta, Georgia 30322-1013

Recruiting

University of Alabama At Birmingham Hospital

Birmingham, Alabama 35294-0004

Recruiting

City of Hope National Medical Center

Duarte, California 91010-3012

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →