This phase I trial studies the side effects and best dose of bendamustine hydrochloride in treating patients with previously treated multiple myeloma. 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.
PRIMARY OBJECTIVES: I. To identify a maximum tolerated dose of bendamustine (bendamustine hydrochloride) in patients with multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the safety of escalating doses of bendamustine in patients with multiple myeloma. II. To describe the response after bendamustine OUTLINE: This is a dose-escalation study. Patients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Given IV
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Maximum tolerated dose of bendamustine
Defined as the dose where no more than 1 out of 6 patients experience dose-limiting toxicities. Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: 2 days
Incidence of toxicity (NCI CTCAE version 4.0)
Graded according to NCI CTCAE version 4.0
Time frame: Up to 92 days following the last administration of study treatment
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