Phase II Study of VDT (VELCADE, Doxil® and Thalidomide) as Frontline Therapy for Patients With Previously Untreated Multiple Myeloma (MM)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of stage I, II, or III multiple myeloma requiring therapy

- No prior systemic therapy for multiple myeloma

- Patients who have received steroids or radiotherapy for cord compression or
spinal cord disease are eligible for this study

- Patients who have received 1 prior course of antimyeloma therapy may be enrolled
at the investigator's discretion provided disease progression is not noted

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Karnofsky performance status 60-100%

- Platelet count ≥ 75,000 cells/mm^3 (< 75,000 cells/mm^3 secondary to extensive bone
marrow disease allowed at the PI's discretion with appropriate transfusion support)

- ANC ≥ 1,000 cells/mm^3

- Hemoglobin ≥ 8.0 g/dL (< 8 g/dL secondary to extensive bone marrow disease allowed at
the PI's discretion with appropriate transfusion support)

- Creatinine clearance > 20 mL/min

- AST and ALT ≤ 2 times upper limit of normal (ULN) OR ≤ 3 times ULN (in the presence
of liver metastases)

- Alkaline phosphatase ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver
metastases)

- Total bilirubin ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)

- Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram

- Negative pregnancy test

- Fertile patients must use at least 1 highly effective and 1 additional effective
contraception method 4 weeks prior to, during, and 3 months after completion of study
therapy

- HIV-negative

- Must have sufficient mental capacity to understand the explanation of the study and
to provide informed consent

- Willingness and ability to comply with the FDA-mandated S.T.E.P.S. program

Exclusion criteria:

- Pregnant or lactating

- Active, serious infections uncontrolled by antibiotics

- Any medical condition or reason that, in the investigator's opinion, makes the
patient unsuitable to participate in this clinical trial

- History of hypersensitivity reactions attributed to a conventional formulation of
doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or
bortezomib, boron, or mannitol

- Any of the following conditions:

- History of uncontrolled New York Heart Association class II-IV heart disease or
clinical evidence of congestive heart failure

- Myocardial infarction within the past 6 months

- Uncontrolled angina

- Severe uncontrolled ventricular arrhythmias, ECG evidence of acute ischemia, or
active conduction system abnormalities

- Peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics