A Phase I/II Study of Immunotherapy With hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients With Multiple Myeloma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks
first 12 weeks, then over 2 years
Yes
William Wegener, MD, PhD
Study Chair
Immunomedics, Inc.
United States: Food and Drug Administration
PROTOCOL: IMMU-115-01
NCT00421525
January 2007
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
New York Presbyterian Hospital/Cornell Medical Center | New York, New York 10021 |
Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
Center for Cancer Care | Goshen, Indiana 46526 |
Hospital University of Pennsylvania | Philadelphia, Pennsylvania 19104 |