A Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01101594|
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : October 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: hLL1-DOX (the doxorubicin conjugate of milatuzumab)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma|
|Study Start Date :||July 2010|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
U.S. FDA Resources
4 Different dose levels of hLL1-DOX will be studied in groups of 3-6 patients. Once an optimal dose has been found, up to additional 30 patients will be studied at that dose level.
Drug: hLL1-DOX (the doxorubicin conjugate of milatuzumab)
hLL1-DOX will be administered intravenously (through a vein) on days 1, 4, 8 & 11 every 21 days for up to 8 treatment cycles. 4 different dose levels of hLL1-DOX will be studied for safety and tolerability.
- Safety [ Time Frame: Safety is measured during the treatment period and for a minimum of 12 weeks after the treatment period for a maximum of 2 years. ]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.
- Efficacy [ Time Frame: Efficacy is measured during and after the study drug treament period for a maximum of 2 years. ]Efficacy endpoints (treatment response, duration of response and time to progression) will be evaluated using the International Myeloma Working Group Response Criteria for multiple myeloma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101594
|United States, Florida|
|MD Anderson Orlando|
|Orlando, Florida, United States, 32806|
|United States, Georgia|
|Georgia Cancer Specialists|
|Atlanta, Georgia, United States, 30068|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, Pennsylvania|
|University Hospital of Pennsylvania|
|Philadelphi, Pennsylvania, United States, 19104|
|United States, Texas|
|MD Anderson Center|
|Houston, Texas, United States, 77030|