NCT00726869

A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m\^2 IV bolus. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (i.e., Days 1 and 11).

Detailed description

The phase 2 portion of this study was not initiated because a decision was made to conduct a phase 2 randomized clinical trial.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elotuzumab (HuLuc63)	Cohort 1 - 2.5 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; Cohort 2 - 5.0 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; Cohort 3 - 10.0 mg/kg elotuzumab IV withbortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; and Cohort 4 - 20.0 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8.

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-08-01
• Last updated: 2012-08-23

Locations

8 sites across 1 country: United States