Overview

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

Status:
Terminated
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BioInvent International AB
Criteria
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.