NCT00718419

A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma

An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom's Macroglobulinemia or Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.

Conditions

• Waldenstrom's Macroglobulinemia
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Enzastaurin	Enzastaurin: Cycle 1 Day 1 only: 3, 125-milligrams (mg) tablets three times on Day 1 (Day 1 total dose = 1125 mg) Day 2 onwards and subsequent Cycles: 2, 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days. Patients may stay on drug past 8 cycles, (until the study is closed) or until disease progression.

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-09-01
• Completion: 2012-08-01
• First posted: 2008-07-18
• Last updated: 2020-09-03
• Results posted: 2020-09-03

Locations

4 sites across 2 countries: United States, France