Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma

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