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A Phase 1b/2 Study of BGB-11417 as Monotherapy and in Various Combinations with Dexamethasone plus Carfilzomib, Dexamethasone plus Daratumumab, and Dexamethasone plus Pomalidomide in Multiple Myeloma
EU CTIS ID: 2023-507751-30-00
What this study is testing
Part 1 (Dose Escalation): To evaluate the safety and tolerability of sonrotoclax in combination with dexamethasone, dexamethasone plus carfilzomib, dexamethasone plus daratumumab, and dexamethasone plus pomalidomide in patients with relapsed/refractory (R/R) multiple myeloma (MM) and t(11;14) To determine the maximum tolerated dose (MTD)/maximum assessed dose (MAD) and recommended Phase 2 dose (RP2D) for sonrotoclax in combination with dexamethasone, dexamethasone plus carfilzomib, dexamethasone plus daratumumab, and dexamethasone plus pomalidomide in patients with R/R MM and t(11;14) Part 2 (Cohort Expansion): To evaluate the safety and tolerability of sonrotoclax monotherapy, as well as the safety and tolerability of sonrotoclax in combination with dexamethasone at RP2D in patients with R/R MM and t(11;14) To evaluate the safety and tolerability of sonrotoclax in combination with dexamethasone plus carfilzomib at the recommended dose for the combination therapy in patients with R/R MM and t(11;14) To evaluate the efficacy of sonrotoclax as monotherapy, in combination with dexamethasone, and with dexamethasone plus carfilzomib in patients with R/R MM and t(11;14) as measured by overall response rate and additional response rates
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- A confirmed diagnosis of multiple myeloma
- Measurable disease defined as: (a) M-spike ≥ 500 mg/dL, or (b) Urine protein M-spike of ≥ 200 mg/day, or (c) Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
- Patient has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy. 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. 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.
- Patients in Part 1 (all cohorts) 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 therapies.
- Patients in Part 2 (Cohorts 1 and 2) 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 therapies.
You likely can't join if
- Patient has any of the following conditions: (a) Non secretory MM (Serum free light chains < 10 mg/dL); (b) Solitary plasmacytoma; (c) Active plasma cell leukemia (5% of peripheral white blood cells); (d) Waldenström macroglobulinemia; (e) Amyloidosis; (f) Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome.
- Chronic respiratory disease that requires continuous oxygen and/or respiratory failure requiring assisted ventilation
- Significant cardiovascular disease, including but not limited to: (a) Myocardial infarction ≤ 6 months before screening; (b) Ejection fraction ≤ 50%; (c) Unstable angina ≤ 3 months before screening; (d) New York Heart Association Class III or IV congestive heart failure; (e) History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes); (f) Heart rate-corrected QT interval > 480 milliseconds based on Fridericia’s formula; (g) History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; (h) Uncontrolled hypertension at screening, defined as systolic blood pressure > 140 mmHg and diastolic blood pressure > 90 mmHg by ≥ 2 consecutive measurements.
- Positive human immunodeficiency virus serology (HIVAb) status.
- Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows: (a) Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients 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. (b) Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- A confirmed diagnosis of multiple myeloma
- Measurable disease defined as: (a) M-spike ≥ 500 mg/dL, or (b) Urine protein M-spike of ≥ 200 mg/day, or (c) Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
- Patient has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy. 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. 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.
- Patients in Part 1 (all cohorts) 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 therapies.
- Patients in Part 2 (Cohorts 1 and 2) 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 therapies.
- Patients in Part 2 (Cohorts 3, 4 and 5): (i) Should have relapsed or progressive disease and have had ≥ 1 prior line of therapy. Patients must have been exposed to a combination therapy containing an anti-CD38 monoclonal antibody. Prior treatment with carfilzomib is allowed, but the patient must not be considered carfilzomib refractory by the investigator.
- Positivity for t(11;14) translocation must be confirmed by a validated FISH assay in a predefined central laboratory: (a) A fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing; (b) Enrollment requires centrally confirmed t(11;14) results.
- Adequate organ function defined as: (a) Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment (transfusions, in accordance with institutional guidelines, are permitted); (b) Platelet count ≥ 75,000/μL within 7 days before first dose of study treatment, independent of growth factor support and transfusions; (c) Absolute neutrophil count (ANC) ≥ 1000/mm3 within 7 days before first dose of study treatment; (d) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN; (e) Creatinine clearance ≥ 45 mL/min/1.73 m2 as calculated by the MDRD-6 formula.
- Patient has any of the following conditions: (a) Non secretory MM (Serum free light chains < 10 mg/dL); (b) Solitary plasmacytoma; (c) Active plasma cell leukemia (5% of peripheral white blood cells); (d) Waldenström macroglobulinemia; (e) Amyloidosis; (f) Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome.
- Chronic respiratory disease that requires continuous oxygen and/or respiratory failure requiring assisted ventilation
- Significant cardiovascular disease, including but not limited to: (a) Myocardial infarction ≤ 6 months before screening; (b) Ejection fraction ≤ 50%; (c) Unstable angina ≤ 3 months before screening; (d) New York Heart Association Class III or IV congestive heart failure; (e) History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes); (f) Heart rate-corrected QT interval > 480 milliseconds based on Fridericia’s formula; (g) History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; (h) Uncontrolled hypertension at screening, defined as systolic blood pressure > 140 mmHg and diastolic blood pressure > 90 mmHg by ≥ 2 consecutive measurements.
- Positive human immunodeficiency virus serology (HIVAb) status.
- Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows: (a) Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients 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. (b) Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Korea, Republic of
- China
- United States
- Israel
- Australia
- Singapore
- Canada
- United Kingdom
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Korea, Republic of; China; United States; Israel; Australia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.