This research study is studying a combination of targeted therapies known as GO-203-2C and bortezomib as a possible treatment for multiple myeloma that has either progressed or not responded to treatment.
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved GO-203-2C as a treatment for any disease. The FDA (the U.S. Food and Drug Administration) has approved bortezomib as a treatment option for your disease. The purpose of this research study is to test the safety of GO-203-2C with bortezomib. GO-203-2C is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1. Myeloma cells harbor an increased amount of MUC1 on its cell surface. By binding to MUC1, GO-203-2C has been shown to cause tumor cell death in laboratory studies. Bortezomib is an intravenously or subcutaneously administered medication that belongs to a class of drugs called proteasome inhibitors. Proteasome inhibitors disrupt the normal action of cells that breakdown proteins in both normal and cancer cells. This disruption can stall tumor growth and cause cancer cells to die. Bortezomib is currently approved for the treatment of multiple myeloma. The Investigators want to find the highest dose of GO-203-2C given in combination with bortezomib that can be administered safely without severe or unmanageable side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
MTD Dose
Time frame: Baseline to 21 Days
Response Rate
Time frame: 12 Months
Progression Free Survival
Estimated using the method of Kaplan and Meier.
Time frame: Start of treatment to disease progression or death from any cause, assessed up to 100 months
Event Free Survival
Estimated using the method of Kaplan and Meier.
Time frame: Time of treatment initiation to Progressive Disease, death, or nonprotocol therapy, assessed up to 100 months
Time-to-new treatment
Estimated using the method of Kaplan and Meier.
Time frame: From treatment initiation to next treatment or death of any cause, assessed up to 100 months
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