Clinical Trial: Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Current Primary Outcome: Maximum tolerated dose of bendamustine [ Time Frame: 2 days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of toxicity (NCI CTCAE version 4.0) [ Time Frame: Up to 92 days following the last administration of study treatment ]

Graded according to NCI CTCAE version 4.0


Original Secondary Outcome: Incidence of toxicity (NCI CTCAE version 4.0) [ Time Frame: Up to 181 days ]

Graded according to NCI CTCAE version 4.0


Information By: Thomas Jefferson University

Dates:
Date Received: December 9, 2014
Date Started:
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016