drugset / Trial / NCT00675428

Study of Natalizumab in Relapsed/Refractory Multiple Myeloma

NCT00675428

Phase 1/2 Terminated 6 enrolled Biogen
RandomizedSingle-groupOpen-labelTreatment

Summary

The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical activity.

Timeline

Start
2008-09
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject natalizumab Monoclonal antibody 300 mg Intravenous
Subject natalizumab Monoclonal antibody 450 mg Intravenous

Indications