Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

DISEASE CHARACTERISTICS:

* Confirmed diagnosis of symptomatic multiple myeloma

  * Durie Salmon stage 2 or higher
  * Previously untreated multiple myeloma (including immunomodulatory drugs such as thalidomide) with the exception of bisphosphonates
* Evaluable or measurable disease, as defined by at least one of the following:

  * Serum monoclonal protein ≥ 1 g/dL (measurable disease)
  * Urine monoclonal protein ≥ 200 mg/24 hours by protein electrophoresis (measurable disease)
  * Serum-free light chains (FLC) ≥ 10 mg/dL, kappa or lambda, accompanied by an abnormal kappa/lambda ratio

Serum FLC's should only be used for patients without measurable serum or urine m-spike

\- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

\* Patients diagnosed with smoldering myeloma or monoclonal gammopathy of undetermined significance are not eligible

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2

  \- ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator
* Total bilirubin normal OR direct bilirubin ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* Creatinine ≤ 3.5 mg/dL
* Absolute neutrophil count ≥ 1,000/mm³ without transfusion or growth factor
* Platelet count ≥ 100,000/mm³ without transfusion or growth factor
* Willingness and the physical and mental capability to provide written informed consent
* Willingness to return to Mayo Clinic Arizona/Princess Margaret Hospital for follow-up
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Exclusion criteria:

* Peripheral sensory neuropathy ≥ grade 2 as defined by National Cancer Institute (NCI) Common Terminology for Common Adverse Events (CTCAE) version 3.0
* Known hypersensitivity to compounds containing boron or mannitol
* Active uncontrolled infection
* Severe cardiac comorbidity including but not limited to:

  * New York Heart Association class III or IV heart failure
  * History of myocardial infarction within the past 6 months
  * Uncontrolled angina or electrocardiographic (ECG) evidence of acute ischemia
  * Severe uncontrolled ventricular arrhythmias or ECG evidence of active conduction system abnormalities
  * Cardiac amyloidosis with hypotension (i.e., systolic blood pressure \< 100 mm Hg)
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent study compliance or completion of study treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior high-dose corticosteroid therapy for 12 days or less is permitted for emergent complications from newly diagnosed multiple myeloma
* More than 14 days since prior investigational agents
* No concurrent steroids or any other anticancer agents or treatments

  \- Patients may receive the equivalent of up to 20 mg prednisone per day for concurrent illness or adrenal replacement therapy
* Concurrent palliative radiotherapy for bony pain or fracture is allowed