Simvastatin in Overcoming Chemotherapy Resistance in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• •Patients must have a definitive diagnosis of multiple myeloma (using the International Myeloma Working Group Guidelines)
• •Patients must meet one of the following two requirements:
• •* Have achieved minimal response (MR) or stable disease (SD) in current treatment regimen after receiving a minimum of two cycles
• •* Have a partial response but show a decrease less than 25% or an increase less than 25% in measurable disease over a two month period
• •* NOTE: Patients may be refractory to primary therapy or relapsed and have measurable or assessable disease; (refractory disease is defined as anything less than partial response \[PR\] or progression within 60 days of completing therapy)
• •Patients with multiple myeloma must have measurable disease; measurable disease may be paraprotein in serum or urine or the presence of free light chains in serum or urine defined by one or more of the following criteria:
• •* Presence of serum M-protein concentration \> 1 g/dL
• •* Urine M-protein excretion \> 200 mg in 24-hour urine collection
• •* Serum free light chain concentration \>= 10 mg/dL and abnormal kappa/lambda ratio
• •* Urine free light chain concentration \>= 100 mg/L and abnormal kappa/lambda ratio
• •If female patient with reproductive capacity: on effective means of barrier birth control during the entire duration of the treatment
• •Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status of 0, 1, or 2 (Karnofsky \>= 60%)
• •Life expectancy of greater than 8 weeks
• •Absolute neutrophil count \>= 500/ul
• •Platelets \>= 30,000/ul
• •Total bilirubin \< 2 times the upper limit of normal
• •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \< 3 x upper limit of normal
• •Patients must have adequate renal function as defined by a creatinine clearance \>= 40 mL/min (measured or estimated by the Cockcroft-Gault formula)
• •Patients must have no signs of significant rhabdomyolysis determined by creatine phosphokinase (CPK) levels with a creatine kinase (CK) \< 5 times the upper limit of normal
• •Patients must have recovered from acute toxicities resulting from therapy administered prior to entering this study to grade 1 or less (Common Terminology Criteria for Adverse Events \[CTCAE\] 4); alopecia may be unresolved
• •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document