H9S-MC-JDCF was a multicenter non-randomized, single-arm, open-label, dose-escalation, dose confirmation, Phase 1 study of intravenous (IV) LY2127399 in combination with bortezomib in patients with refractory or relapsed MM.
This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the safety of LY2127399 in combination with bortezomib and any side effects that might be associated with it; (2)Assess whether LY2127399 in combination with bortezomib may help patients with relapsed or refractory multiple myeloma; (3)How much LY2127399 should be given to patients along with bortezomib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
monoclonal antibody
University of Alabama
Birmingham, Alabama, United States
UCLA
Los Angeles, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Pharmacokinetic (PK)/Pharmacodynamic (PD)modeling of LY2127399 to determine a Phase 2 dose
Time frame: 2 years
Safety and toxicity profile for LY2127399 in combination with bortezomib
Time frame: 2 years
Response rate, duration of response, and time to progression of LY2127399 in combination with bortezomib
Time frame: 2 years
Response rate, duration of response, and time to progression of LY2127399 as a single-agent
Time frame: 2 years
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States