Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Inclusion

• ANC >= 1500/uL
• AST = = 30 mL/minute
• Patients with relapsed or refractory multiple myeloma requiring treatment
• Patients who have received prior bortezomib therapy will be allowed on trial as long as they did not progress during bortezomib or = = 12 weeks
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
• Male subject agrees to use an acceptable method for contraception for the duration of the study
• Patients have a baseline LVEF >= 45% at baseline
• Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
• PLT >= 100,000/uL
• Total bilirubin = 1.5 x ULN, the direct bilirubin must be = = 1.0 g/dL, >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis, serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio, monoclonal bone marrow plasmacytosis >= 30% (evaluable disease), or measurable plasmacytoma
• ECOG Performance Status (PS) 0, 1, or 2
• Hgb >= 9 g/dl

Exclusion

• Major surgery, open biopsy (excluding bone marrow) or significant traumatic injury = =Grade 2 peripheral neuropathy within 14 days before enrollment
• Patient has received other investigational drugs with 14 days before enrollment
• Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
• Infection requiring systemic antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection
• Inability to swallow orally administered medication
• Prior allogeneic bone marrow or organ transplantation
• Patients who are currently receiving digoxin, cyclosporine, tacrolimus or sirolimus
• Severe cardiac comorbidity
• Known positive for HIV or active infectious hepatitis, type A, B or C