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

Korábbi kezelés

• Currently taking supplements containing either curcumin or piperine.
• Plan to start any additional over the counter supplements prior to or during trial period.
• Evidence of any of the following conditions per subject self-report or medical chart review: Major surgery or significant traumatic injury occurring within 4 weeks before enrollment.

Más betegség

• For prostate cancer patients must not be planning to undergoing primary curative therapy for their prostate cancer (radiation, surgery, brachytherapy).
• For MGUS/ SMM patients, must not have had evidence of disease progression which might require treatment during the one-year study period.
• Other: symptomatic plasma cell leukemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein).

Egyéb

• Subject is pregnant or breast feeding, or planning to become pregnant during the treatment period.

• 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.