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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
twice weekly dosing for 4 weeks, total of 8 doses
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Center for Cancer Care
Goshen, Indiana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks
Time frame: first 12 weeks, then over 2 years
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
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New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States
Hospital University of Pennsylvania
Philadelphia, Pennsylvania, United States