Clinical Trials

Inclusion

• Creatinine ≤ 2 mg/dL
• Calculated Creatinine Clearance ≥ 30 mL/min
• Total Bilirubin ≤ 2.0 mg/dL
• Alkaline Phosphatase ≤ 3 x ULN
• ALT ≤ 3 x ULN
• Absolute neutrophil count ≥ 1000/uL
• Platelet ≥ 75000/uL
• Hemoglobin ≥ 8.0 g/dL
• Untreated symptomatic myeloma: Prior non-systemic therapy for the treatment of solitary plasmacytoma is permitted, but ≥ 1 month should have elapsed from the last day of radiation; prior therapy with clarithromycin, DHEA, anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the Principal Investigator
• Prior high dose corticosteroid therapy for twelve days (480 mg total dose) or less is permitted for emergent complications from newly diagnosed multiple myeloma
• Measurable disease of multiple myeloma, as defined by at least ONE of the following:
• Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
• OR > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
• OR serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio; OR monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
• ECOG performance status (PS) 0, 1, 2; ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator
• Willingness and able to provide informed written consent
• Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
• Willingness to return to Mayo Clinic enrolling institution for follow-up

Exclusion

• MGUS or smoldering myeloma
• Peripheral sensory neuropathy ≥ Grade 2 as defined by CTEP Active Version of the CTCAE
• Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer
• Pregnant women or women of reproductive ability who are unwilling to use effective contraception
• Nursing women
• Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
• Known hypersensitivity, allergy or inability to tolerate any of the agents employed
• Active, uncontrolled infection
• Severe cardiac comorbidity
• New York Heart Association Class III or IV Heart Failure
• Recent history of myocardial infarction in the six months prior to registration
• Uncontrolled angina or electrocardiographic evidence of acute ischemia
• Severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of active conduction system abnormalities
• Cardiac amyloidosis with hypotension (systolic BP less than 100 mmHg)
• Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
• The following medications are not permitted during the trial: any other investigational treatment; any cytotoxic chemotherapy; any other systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
• Palliative radiation therapy is permitted if clinically indicated and not indicative of progressive disease