Multiple Myeloma Clinical Trial
Official title:
Phase I Study of Everolimus + Bendamustine in Patients With Relapsed/Refractory Hematological Malignancies
This phase I trial studies the side effects and the best dose of everolimus when given together with bendamustine hydrochloride in treating patients with cancer of the blood (hematologic cancer) that has returned after a period of improvement (relapsed) or did not get better with a particular treatment (refractory). Everolimus may prevent cancer cells from growing by blocking a protein that is needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, 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. Giving everolimus together with bendamustine hydrochloride may be a better treatment for hematologic cancer.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of everolimus when administered in
combination with bendamustine (bendamustine hydrochloride) in defined hematologic
malignancies.
II. To determine the safety and tolerability of administering everolimus in combination with
bendamustine chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the efficacy of everolimus when administered in combination with bendamustine
in adult patients with relapsed/refractory hematological malignancies.
OUTLINE: This is a dose-escalation study of everolimus.
Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and
2 and everolimus orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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