A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma
In this clinical research trial, hLL1-DOX will be administered on days 1, 4, 8 and 11. This
treatment cycle will be repeated every 3 weeks as long as patients continue to tolerate it,
for a maximum of 8 treatment cycles (approximately 6 months).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety
Safety evaluations include monitoring for infusion reactions or other acute adverse events, cardiac assessments (EKG, troponin T, BNP, MUGA scan or 2D-ECHO), vital signs, physical examination, routine safety laboratories (hematology, serum chemistries, urinalysis), serum immunoglobulins, and B- and T-cell levels, with immunogenicity analyzed by the Sponsor from human anti-milatuzumab antibody serum titers (HAHA). Antibody pharmacokinetics will be evaluated by hLL1-DOX serum levels analyzed by the Sponsor.
Safety is measured during the treatment period and for a minimum of 12 weeks after the treatment period for a maximum of 2 years.
Yes
United States: Food and Drug Administration
IM-T-hLL1-DOX-01
NCT01101594
July 2010
June 2015
Name | Location |
---|---|
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
University Hospital of Pennsylvania | Philadelphia, Pennsylvania 19104 |
MD Anderson Orlando | Orlando, Florida 32806 |
MD Anderson Center | Houston, Texas 77030 |