Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02315157
Status:
WITHDRAWN
Last Update Posted:
2025-10-15
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Study Overview
Official Title:
Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn by PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: