NCT00421525

Phase I/II Study of hLL1 in Multiple Myeloma

A Phase I/II Study of Immunotherapy With hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or refractory multiple myeloma who have failed at least two prior standard systemic treatments.

Detailed description

All patients receive hLL1 administered intravenously twice weekly for 4 consecutive weeks. Cohorts of 3-6 patients will receive escalating doses of hLL1 in order to determine the maximum tolerated dose (MTD) for this administration schedule. Up to approximately 30 additional patients will be entered at one or more dose levels at or below the MTD in order to determine the optimal dose for subsequent studies.

Conditions

• Multiple Myeloma
• Myeloma, Plasma-Cell
• PLASMACYTOMA

Interventions

Type	Name	Description
BIOLOGICAL	milatuzumab	twice weekly dosing for 4 weeks, total of 8 doses

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-01-12
• Last updated: 2021-08-16

Locations

6 sites across 1 country: United States