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

Completed · Phase 2

Conditions studied: Prostate Cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance

In brief

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.

Key facts

Study ID

NCT04731844

Run by

University of Rochester

People needed

30

Starts

2021-12-14

Expected to finish

2024-09-19

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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