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

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg twice a day in early stage prostate cancer patient undergoing active surveillance or patients on observation for MGUS/ low-risk smoldering myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Curcumin; Piperine

Criteria

Inclusion Criteria:

• 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).

1. 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.

2. 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.

Exclusion Criteria

• Currently taking supplements containing either curcumin or piperine.

• Plan to start any additional over the counter supplements prior to or during trial period.

• 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).

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