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

NCT04731844 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UMLT20123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Multiple Myeloma; Smoldering Multiple Myeloma (SMM); Monoclonal Gammopathy of Undetermined Significance

Keywords

curcumin; peperine; prostate cancer; Multiple Myeloma; Smoldering Multiple Myeloma (SMM); Monoclonal Gammopathy of Undetermined Significance (MGUS)

Outcome Measures

Primary Outcomes (1)

• Response Rate of Curcumin & Piperine Supplementation in Patients on Active Surveillance for Either Early Stage Prostate Cancer or Patients on Observation for MGUS/Low-risk Smoldering Myeloma.

  To estimate the proportion of participants achieving a disease-specific response following curcumin and piperine supplementation administered at a dose of 2gm/10mg(2 tablets) orally twice daily for up to 12 months. For patients with early-stage prostate cancer, response was defined as ≥50% decrease in prostate-specific antigen (PSA) from baseline, confirmed at least 4 weeks apart. For patients with MGUS or low-risk SMM, response was defined per International Myeloma Working Group (IMWG) criteria as at least a partial response (≥50% reduction in serum M-protein). The overall response rate equals the number of participants achieving disease-specific response divided by total number analyzed.

  From date of enrollment until the date of first documented response assessed up to 12 months

Secondary Outcomes (2)

• Percentage of Participants Without Disease Progression or Death at 12 Months

  From enrollment to 12 months

• Safety and Tolerability of Curcumin in Combination With Piperine

  From start of study treatment through study completion, an average of 1 year for non-serious adverse events; and from screening through study completion, an average of 1 year for serious adverse events.

Study Arms (3)

Prostate Cancer

EXPERIMENTAL

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Drug: Curcumin plus Piperine

Smoldering Multiple Myeloma (SMM)

EXPERIMENTAL

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Drug: Curcumin plus Piperine

Monoclonal Gammopathy of Unknown Significance (MGUS)

EXPERIMENTAL

Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months

Drug: Curcumin plus Piperine

Interventions

Curcumin plus Piperine DRUG

Curcumin with piperine is a well-tolerated over-the-counter supplement.

Also known as: Curcumin C3 Complex®

Monoclonal Gammopathy of Unknown Significance (MGUS); Prostate Cancer; Smoldering Multiple Myeloma (SMM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Multiple Myeloma; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance

Interventions

Curcumin; piperine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Brea Lipe
• Organization: University of Rochester

Brea_Lipe@URMC.Rochester.edu

(585) 273-1276

Study Officials

• Brea Lipe

  University of Rochester Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: December 14, 2021
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Locations

US (1)