Back to resultsBendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
Primary Purpose
Multiple Myeloma, Plasma Cell Leukemia
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Partial Response
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
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bendamustine 200 mg/m2
Bendamustine 250 mg/m2
Arm Description
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of toxicity (NCI CTCAE version 4.0)
Graded according to NCI CTCAE version 4.0
Full Information
NCT ID
NCT02315157
First Posted
December 9, 2014
Last Updated
October 19, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT02315157
Brief Title
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
Official Title
Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn by PI
Study Start Date
undefined (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Plasma Cell Leukemia
Keywords
Partial Response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bendamustine 200 mg/m2
Arm Type
Experimental
Arm Description
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).
Arm Title
Bendamustine 250 mg/m2
Arm Type
Experimental
Arm Description
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treakisym, Ribomustin, Levact, Treanda, SDX-105
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Maximum tolerated dose of bendamustine
Description
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
Secondary Outcome Measure Information:
Title
Incidence of toxicity (NCI CTCAE version 4.0)
Description
Graded according to NCI CTCAE version 4.0
Time Frame
Up to 92 days following the last administration of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Sharma, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Jefferson University Hospitals
Learn more about this trial
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
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