The following criteria is provided for health care professionals.
Major Inclusion Criteria:
- Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
- Measurable disease defined as at least one of the following:
- Serum M-protein ≥0.5 g/dL
- Urine M-protein ≥200 mg/24 hours
- Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate hematologic status, including:
- Absolute neutrophil count (ANC) ≥1000 cells/μL
- Platelet count ≥50,000/μL (without transfusions)
- Hemoglobin ≥8 g/dL
- Adequate renal function, including:
- Calculated creatinine clearance ≥30 mL/min using the formula of Cockcroft and Gault
- Adequate hepatic function, including
- Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct bilirubin
- AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement)
- Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement)
Major Exclusion Criteria:
- Prior exposure to BCMA-targeting agents (Part 2 only)
- Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening