Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma

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