Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

* Histologic confirmation of multiple myeloma
* Patients must have active multiple myeloma requiring first line treatment
* At least 18 years of age
* Female patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 3 months after completing treatment.
* Male patient agrees to use an acceptable method of contraception for the duration of the study and for 3 months after completing treatment.
* Expected survival of at least 6 months
* Patients with abnormal kidney function, including patients on dialysis, are eligible if kidney insufficiency is secondary to multiple myeloma.
* Patients must have adequate liver functions
* Patients may have received up to 2 weeks of high dose steroids. Prior steroid treatment for more than 2 weeks is allowed provided the treatment was given for neurological compromise.
* Prior radiation therapy will be allowed but radiation therapy must be completed prior to registration.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Patient had a myocardial infarction within 6 months of enrollment, history of cardiac disease, or clinical evidence of congestive heart failure.
* Patient previously received 250 mg/m2 or more of doxorubicin (or equivalent for other anthracyclines).
* Patient is known to be human immunodeficiency virus (HIV)-positive (patients assessed to be at risk should be tested).
* Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection (patients assessed by the investigator to be at risk should be tested)
* Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.
* Patient has hypersensitivity to bortezomib, boron or mannitol, conventional doxorubicin HCL or the components of Doxil, or other study drugs.
* Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
* Patient is currently receiving other investigational drug(s).