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

Overview

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.

SparkCures ID 1142
Trial Phase Phase 2
Enrollment 40 Patients
Treatments
  • Curcumin
  • Piperine
Trial Sponsors
  • University of Rochester
NCT Identifier

NCT04731844

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

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.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

New York
University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Resources

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