Efficacy of Curcumin and Piperine in Patients on Active Surveillance for Either Monoclonal Gammopathy of Unknown Significance (MGUS), Low-risk Smoldering Multiple Myeloma (SMM) or Early Stage Prostate Cancer: A Pilot Study

UMLT20123

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.

2021-12-14

2024-05-31

2024-05-31

Recruiting

Early phase I

40

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-07-14