Multiple Myeloma Clinical Trial

Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of treatment-for-multiple-myeloma-induction-therapy/" >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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Study ID:

NCT02315157

Recruitment Status:

Withdrawn

Sponsor:

Sidney Kimmel Cancer Center at Thomas Jefferson University

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There is 1 Location for this study

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Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States

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Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Study ID:

NCT02315157

Recruitment Status:

Withdrawn

Sponsor:


Sidney Kimmel Cancer Center at Thomas Jefferson University

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