A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy

Inclusion Criteria

• •Must have documented, confirmed active multiple myeloma (MM) with greater than or equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:
• •* Evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the protocol specified laboratory criteria for calcium elevation, renal failure, anemia, or lytic bone lesions; OR
• •* One or more of the biomarkers of malignancy as described in the protocol.
• •Must have MM positive for the t(11;14) translocation, as determined by methods described in the protocol.
• •Must have measurable disease defined by at least one of the following criteria:
• •* Serum M-protein ≥ 1.0 g/dL (immunoglobulin \[Ig\]G myeloma) or greater than or equal to 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);
• •* Urine M-protein greater than or equal to 200 mg/24 hours;
• •* Serum free light chain (FLC) greater than or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
• •Newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT)
• •Must have Eastern Cooperative Oncology Group performance status less than or equal to 2.