Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

Disease Characteristics:

Patient previously diagnosed with multiple myeloma; Durie-Salmon Stage I, II, or III based on standard criteria
Progressive disease. For non-secretory multiple myeloma, progressive disease is defined as bone marrow biopsy with > 25% increase in plasma cells or an absolute increase of at least 10% over prior known level. Alternatively, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dL), or relapse from complete response.

Patient Characteristics:

18 yrs or older
Patient has given voluntary written informed consent.
Unless post-menopausal or surgically sterilized, a female must be willing to use an acceptable method of birth control
Male patient must agree to use an acceptable method for contraception for the duration of the study.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Life expectancy is at least 3 months.

• Absolute Neutrophil Count (ANC) over 1,000/ul without the use of colony stimulating factors

Platelets over 50,000/ul without transfusion support 7 days
Bilirubin 2.0 mg/dl or less
aspartate aminotransferase (AST) 4 times or less upper limit normal Prior Therapy for Multiple Myeloma: Patients must have had at least 2 prior therapeutic regimens

Exclusion Criteria:

Pregnant or breast feeding
History of allergic reaction to compounds containing boron or mannitol.
Active uncontrolled viral (including HIV), bacterial, or fungal infection.
Grade III or IV toxicity due to previous anti-neoplastic therapy
More than Grade 2 motor or sensory neuropathy
Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia.
For any patients whose lifetime cumulative doxorubicin dose exceeds 400mg/m2, patients with left ventricular ejection fraction (LVEF) less than 35% by multigated acquisition (MUGA) .
Concurrent administration of liposomal doxorubicin, melphalan, and bortezomib (single or two drug combinations of these are permissible)
Less than 3 weeks since most recent chemotherapy or concurrent chemotherapy
Use of corticosteroids (mroe than 10 mg prednisone/day or equivalent)