This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is attached to doxorubicin in this clinical trial.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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.
MD Anderson Orlando
Orlando, Florida, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
All patients administered any dose of study drug will be included in the evaluation of safety
The frequency and severity of adverse events (AEs) will be tabulated by MedDRA Preferred Term and System Organ Class (SOC) for each dose group. AEs will be classified using the MedDRA version 8.0 with severity assessed by NCI CTC v3 toxicity grades
Time frame: Before infusion, 5 min after start, every 15 min until completion, then 30, 60, 90 and 120 min later of each dose of study drug
Determine the therapeutic efficacy of hLL1-DOX in this patient population
All patients who were treated with at least one complete dose of study drug and have available response assessment data will constitute the efficacy population. For efficacy evaluations, treatment responses based on IMWG Response Criteria, response duration and progression-free survival will be tabulated and summarized by descriptive statistics for patients in each dose group.
Time frame: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years
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MD Anderson Center
Houston, Texas, United States