Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer

Inclusion Criteria17

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
• Age ≥ 18 years of age.
• Karnofsky performance status (KPS) of ≥ 70%.
• Subjects with either 1) non-metastatic biopsy proven adenocarcinoma of the prostate who have chosen AS the treatment option for their prostate cancer or 2) have the diagnosis of either MGUS or low-risk SMM and are currently on observation alone.
• For patients with MGUS or low-risk SMM, diagnosis must be according to the definition of the International Myeloma Working Group (IMWG).
• MGUS: serum M-protein \<3.0g/dL, \<10% clonal plasma cells (PCs) in the bone marrow, and absence of end-organ damage (CRAB criteria) that can be attributed to the plasma cell disorder.
• SMM: serum M-protein of ≥3.0g/dL or a proportion of clonal PCs in the BM of ≥10% but \<60%, and no evidence of end organ damage as described below.
• Absence of end organ damage is defined by absence of CRAB criteria:
• C: Absence of hypercalcemia, defined as calcium ≤11mg/dL.
• R: Absence of renal failure, defined as serum creatinine ≤2.0mg/dL.
• A: Absence of anemia, defined as hemoglobin ≥10g/dL.
• B: Absence of lytic bone lesions per IMWG recommendations: One of either PET-CT, low-dose whole-body CT, or whole- body MRI. Increased uptake on PET-CT alone is not adequate for the diagnosis of multiple myeloma; evidence of underlying osteolytic bone destruction is needed on the CT portion of the examination.
• At least one of the risk factors below that portends for an increased risk of progression to MM:
• Abnormal serum free light chain ratio.
• M-spike ≥2.0g/dL.
• ≥ 20% bone marrow clonal plasma cells.
• Immunoparesis ≥20% reduction from institutional normal standard of uninvolved immunoglobulins.