Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma, Plasma Cell Leukemia

Intervention / Treatment
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* Drug: Bendamustine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine 200 mg/m2<br>Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2). | Drug: Bendamustine<br>* Given IV<br>* Other names: SDX-105;|
| Experimental: Bendamustine 250 mg/m2<br>Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2). | Drug: Bendamustine<br>* Given IV<br>* Other names: SDX-105;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial Response