A Phase II Study of BI-505 in Smoldering Multiple Myeloma

Inclusion Criteria: * Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria: * Serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10 percent. * Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder. * Male or female, 18 years or older. * Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1. Exclusion Criteria: * Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma. * Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator. * Severe other conditions.