NCT00689507

A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib

A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Applied Molecular Evolution · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in patients with refractory or relapsed MM.

Detailed description

This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the safety of LY2127399 in combination with bortezomib and any side effects that might be associated with it; (2)Assess whether LY2127399 in combination with bortezomib may help patients with relapsed or refractory multiple myeloma; (3)How much LY2127399 should be given to patients along with bortezomib.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	LY2127399	monoclonal antibody

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-01-01
• Completion: 2014-05-01
• First posted: 2008-06-03
• Last updated: 2015-06-29

Locations

6 sites across 1 country: United States