Bendamustine Hydrochloride in Treating Patients With Prev... | NCT02315157

Studies
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

NCT02315157

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Status

Withdrawn

Last Update Posted

Oct 15, 2025Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Multiple Myeloma
Plasma Cell Leukemia

Interventions

Bendamustine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-009	Other Identifier	CCRRC
JT 5775	Other Identifier	JeffTrial Number

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn by PI

Expanded Access Info

Start Date

Jun 2014Estimated

Primary Completion Date

Nov 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Dec 9, 2014

First Submission Date that Met QC Criteria

Dec 10, 2014

First Posted Date

Dec 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2025

Last Update Posted Date

Oct 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bendamustine 200 mg/m2	Experimental	Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).	Drug: Bendamustine
Bendamustine 250 mg/m2	Experimental	Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).	Drug: Bendamustine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bendamustine	Drug	Given IV	Bendamustine 200 mg/m2 Bendamustine 250 mg/m2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of toxicity (NCI CTCAE version 4.0)	Graded according to NCI CTCAE version 4.0	Up to 92 days following the last administration of study treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy
Age up to 80 years
ECOG Performance Status of 0 or 1
Left ventricular ejection fraction =/> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
FEV1, FVC and DLCO =/> 40%. No symptomatic pulmonary disease.
Serum bilirubin <2 x upper limit of normal, alkaline phosphatase <3 x upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites > 1 L prior to drainage.
HIV negative
Negative beta HCG test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization
Patients or guardian able to sign informed consent
Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34 cells/kg)
Calculated GFR > 50 ml/minute

Exclusion Criteria:

Patients with uncontrolled hypertension (systolic > 140, diastolic > 90 despite antihypertensive therapy
Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms)
New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Relapsed/refractory myeloma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Label	URL
Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center	View source
Jefferson University Hospitals	View source

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

ID	Term
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

ID	Term
D009101	Multiple Myeloma
D007952	Leukemia, Plasma Cell