A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria
M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks.
Markus Hansson, MD, PhD
Department of Hematology,Skåne University Hospital
Sweden: Medical Products Agency