Status:
TERMINATED
A Phase II Study of BI-505 in Smoldering Multiple Myeloma
Lead Sponsor:
BioInvent International AB
Conditions:
Smoldering Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01838369
Start Date
March 1 2013
End Date
December 1 2014
Last Update
January 11 2023
Active Locations (1)
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1
Department of Hemtaology, Skåne University Hospital
Lund, Sweden, SE-22185