Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

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.

Inclusion Criteria:

1. Patients with multiple myeloma who have not achieved a CR following at least 4 cycles
of induction therapy

2. Age up to 80 years

3. ECOG Performance Status of 0 or 1

4. Left ventricular ejection fraction =/> 40%. No uncontrolled arrhythmias or
symptomatic cardiac disease

5. FEV1, FVC and DLCO =/> 40%. No symptomatic pulmonary disease.

6. 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.

7. HIV negative

8. Negative beta HCG test in woman with child bearing potential, defined as not
post-menopausal for 12 months or no previous sterilization

9. Patients or guardian able to sign informed consent

10. Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34
cells/kg)

11. Calculated GFR > 50 ml/minute

Exclusion Criteria:

1. Patients with uncontrolled hypertension (systolic > 140, diastolic > 90 despite
antihypertensive therapy

2. Patients with uncontrolled bacteria, viral or fungal infections (currently taking
medication and progression of clinical symptoms)

3. 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

4. Relapsed/refractory myeloma