Dendritic Cell DKK1 Vaccine for Monoclonal Gammopathy and Stable or Smoldering Myeloma

Inclusion Criteria

• •At any time prior to enrollment subjects must have IgG, IgA, kappa, or lambda monoclonal gammopathy confirmed in at least two assessments at least three months apart or histologically confirmed multiple myeloma or carry a diagnosis of smoldering myeloma based on prior documentation of serum m-spike (IgG or IgA) of at least 3g/dL serum m-spike (IgG or IgA) or 24h urine m-spike of at least 500mg/24h.
• •Within 28 days prior to enrollment persistence of the clonal plasma cell disorder must be documented by presence of a clonal band on immunofixation of blood or urine or an abnormal serum free kappa/lambda ratio.
• •Subjects with myeloma related organ dysfunction must have received prior therapy, reached at least partial remission with at least one of any number of prior regimens, and be candidates for observation off myeloma therapy based on lack of progression at least stable disease for at least 90 days prior to at study entry.
• •Performance status ECOG performance status ≤ 2.
• •Subjects must have laboratory test results within the following ranges:
• •* Hemoglobin ≥ 9.0 g/dl
• •* Absolute neutrophil count ≥ 1,500/mcL
• •* Platelet count ≥ 100,000/mcL
• •* Total bilirubin \< 2.5 x institutional upper limit of normal
• •* AST (SGOT) ≤ 2.5 X institutional upper limit of normal
• •* ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
• •* Calculated creatinine clearance (Cockcroft-Gault) ≥ 30ml/min
• •Anti-myeloma treatment with proteasome inhibitors, IMiDsTM, corticosteroids, low dose cyclophosphamide (≤ 50mg per day) must have been discontinued at least 14 days prior to study entry. Conventional chemotherapy at conventional doses including cyclophosphamide at \> 50mg per day must have been discontinued at least 28 days prior to study entry. At least 180 days must have passed since high dose chemotherapy used in the context of autologous stem cell transplantation. Prior radiation must have been completed at least 14 days prior to enrollment.
• •Subjects must have the ability to understand and the willingness to sign a written informed consent document.