Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

1. Previous therapy for multiple myeloma with the exception of an initial 4-day course of pulsed dexamethasone.

2. Patients with ≥NCI CTCAE v4.0 grade 2 peripheral neuropathy ≤14 days prior to study enrollment.

3. Treatment with investigational agent(s) ≤14 days prior to study enrollment.

4. Active infection or infection requiring intravenous antibiotic treatment at the time of accrual.

5. Known to be HIV positive (HIV test is not required for participation in the trial).

6. Patients with class III/IV cardiac problems as defined by the New York Heart Association (NYHA)criteria:

* History of uncontrolled or symptomatic angina

* History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation

* Myocardial infarction \< 6 months from study entry

* Uncontrolled or symptomatic congestive heart failure

* Ejection fraction below the institutional normal limit

* Any other cardiac condition that, in the opinion of the treatment physician, would make this protocol unreasonably hazardous for the patient

* Uncontrolled hypertension (systolic blood pressure \[BP\] \>180 or diastolic BP \>100mm Hg)or uncontrolled cardiac arrhythmias.

* Prior to study entry, any ECG abnormality at Screening must be documented by the investigator as not medically relevant.

7. Other serious medical conditions or psychiatric illness that would potentially interfere with patient participation in this trial.

8. A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix,unless the tumor was treated with curative intent at least 2 years previously or low-risk prostate cancer after curative therapy.

9. Known hypersensitivity to bortezomib, boron, or mannitol.

10. Female patient is pregnant or lactating. Confirmation that female patients of childbearing potential are not pregnant must be established by a negative serum pregnancy test ≤7 days prior to start of treatment.

What this study is about