Sponsor's decision

The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with 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.