NCT00675428

Study of Natalizumab in Relapsed/Refractory Multiple Myeloma

A Phase 1/2, Two-Arm, Dose-Finding Study of Natalizumab for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Despite no protocol-defined study stopping criteria being met, the sponsor decided to terminate enrollment after the phase 1 portion was complete and to not move into the phase 2 portion of the study. This decision was made due to difficulty enrolling participants and was not due to any safety concerns.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	BG00002 (natalizumab)

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-05-09
• Last updated: 2014-09-19
• Results posted: 2014-09-19

Locations

2 sites across 1 country: United States