Doxorubicin Hydrochloride Liposome, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma based on the following criteria:

Major criteria

Plasmacytomas on tissue biopsy (1)
Bone marrow plasmacytosis (> 30% plasma cells) (2)
Monoclonal immunoglobulin spike on serum electrophoresis IgG > 3.5 g/dL or IgA > 2.0 g/dL and kappa or lambda light chain excretion > 1 g/day on 24-hour urine protein electrophoresis (3)

Minor criteria

Bone marrow plasmacytosis (10% to 30% plasma cells) (a)
Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria (b)
Lytic bone lesions (c)
Normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL (d)

Meets 1 of the following sets of diagnostic criteria:

Any two of the major criteria
Major criteria 1 and minor criteria b, c, and d
Major criteria 3 and minor criteria a or c
Minor criteria a, b, c, OR a, b, d

Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/24 hours, or evidence of lytic bone disease

No nonmeasurable disease (i.e., non-secretory or oligosecretory multiple myeloma)
Symptomatic, newly diagnosed, and previously untreated multiple myeloma
No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein], and skin changes)
No plasma cell leukemia

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
Life expectancy > 3 months
ANC ≥ 1,500/mm^³ (≥ 1,000/mm^³ if bone marrow is extensively infiltrated)
Platelet count ≥ 75,000/mm^³ (≥ 50,000/mm^³ if bone marrow is extensively infiltrated)
Hemoglobin ≥ 8.0 g/dL
AST and ALT ≤ 3.0 times upper limit of normal (ULN)
Serum bilirubin ≤ 2.0 times ULN
Creatinine clearance ≥ 30 mL/min OR creatinine > 10 mL/min and < 30 mL/min for patients with significant myelomatous involvement of the kidneys
Serum potassium ≥ lower limit of normal (LLN)
Serum sodium ≥ LLN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No peripheral neuropathy ≥ grade 2 within past 14 days

No impaired cardiac function or clinically significant cardiac disease, including any one of the following:

Myocardial infarction within the past 6 months
New York Heart Association class II-IV heart failure
Uncontrolled angina
Clinically significant pericardial disease
Severe uncontrolled ventricular arrhythmias
LVEF below normal by ECHO or MUGA scan

ECG evidence of acute ischemia or active conduction system abnormalities

Screening ECG abnormality must be documented by the investigator as not medically relevant
No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL [3.5 mmol/L])
No poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could preclude study treatment

No known HIV positivity or hepatitis B or C positivity

Baseline testing for HIV and hepatitis B or C is not required
No history of allergic reaction attributable to compounds of similar chemical or biological composition to doxorubicin, bortezomib, boron, or mannitol

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No prior or concurrent anti-myeloma therapy except steroids

Prior prednisone for ≤ 4 days at a total of 400 mg (or an equivalent potency of another steroid) allowed
No concurrent corticosteroids (≥ 10 mg prednisone/day or equivalent) other than dexamethasone

More than 4 weeks since prior major surgery and recovered

Prior kyphoplasty with oncotherapeutic drugs allowed at the investigator's discretion
More than 4 weeks since prior immunotherapy, antibody therapy, or radiotherapy
More than 14 days since other prior and no other concurrent investigational drugs