Study on BGB-11417 Alone and in Combination with Dexamethasone and Carfilzomib for Multiple Myeloma

Inclusion Criteria

• Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Must have a confirmed diagnosis of multiple myeloma with specific protein markers in the blood or urine.
• Must have measurable disease, such as a certain level of M-protein in the blood or urine, or abnormal free light chains.
• Must have relapsed or progressive multiple myeloma after previous treatments, or be resistant to the most recent treatment.
• For Part 1, must have tried and not responded to at least three different treatment regimens, including a proteasome inhibitor, an IMiD agent, and an anti-CD38 antibody.
• For Part 2, must have tried and not responded to between one and seven previous treatments, including a proteasome inhibitor and an IMiD agent.
• Must not be resistant to carfilzomib and must not have used it in the past six months.
• Must test positive for a specific genetic marker (t(11;14)) in a bone marrow sample.
• Must have adequate organ function, including specific levels of hemoglobin, platelets, neutrophils, liver enzymes, and kidney function.

Exclusion Criteria

• Cannot have non-secretory multiple myeloma, solitary plasmacytoma, active plasma cell leukemia, Waldenström macroglobulinemia, amyloidosis, or POEMS syndrome.
• Cannot have uncontrolled diabetes or chronic respiratory disease requiring continuous oxygen.
• Cannot have significant heart disease, such as recent heart attack, low heart function, unstable angina, severe heart failure, serious arrhythmias, or uncontrolled high blood pressure.
• Cannot have an active HIV infection.
• Cannot have active hepatitis B or C infections, unless specific conditions are met for monitoring and control.