Clinical Trial: Phase I/II Study of hLL1 in Multiple Myeloma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Immunomedics, Inc.

Current Primary Outcome: safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks [ Time Frame: first 12 weeks, then over 2 years ]

Original Primary Outcome: The primary objectives are to evaluate the safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks, and to determine the maximum tolerated dose (MTD) for this dosing schedule.

Current Secondary Outcome: The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies. [ Time Frame: first 12 weeks, then over 2 years ]

Original Secondary Outcome: The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.

Information By: Immunomedics, Inc.

Dates:
Date Received: January 11, 2007
Date Started: January 2007
Date Completion:
Last Updated: October 3, 2012
Last Verified: October 2012