Recurrent Plasma Cell Myeloma Clinical Trial
Official title:
A Phase I Study of Arry-520 and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma
This phase I trial studies the side effects and best dose of filanesib when given together with carfilzomib in treating patients with multiple myeloma or plasma cell leukemia that has returned or does not respond to treatment. Drugs used in chemotherapy, such as filanesib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filanesib together with carfilzomib may be a better treatment for multiple myeloma or plasma cell leukemia.
PRIMARY OBJECTIVES:
I. To determine the safety and the maximum-tolerated dose (MTD) of filanesib (ARRY-520) when
combined with carfilzomib.
SECONDARY OBJECTIVES:
I. To obtain preliminary estimates of the efficacy of ARRY-520 when combined with
carfilzomib.
II. To explore potential markers for patient selection and obtain a preliminary assessment of
the biological activity of ARRY-520 when combined with carfilzomib.
OUTLINE: This is a dose-escalation study.
Patients receive filanesib intravenously (IV) over 1 hour on days 1, 2, 15, and 16 and
carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity. After 8 courses of
therapy, patients may continue with dosing of carfilzomib on days 1, 2, 15, and 16 and
filanesib as tolerated. If patient progresses on carfilzomib maintenance with administration
on days 1, 2, 15, and 16 they may increase the intensity and add in days 8 and 9 dosing.
After completion of study treatment, patients are followed up within 30 days and then
periodically thereafter.
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