Mode
Text Size
Log in / Sign up
Phase 2 N=29 Treatment

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

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

Enrolled (actual)
29
Serious AEs
3.5%
Results posted
May 2026
Primary outcome: Primary: 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. — 10; 7; 8 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Curcumin plus Piperine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Rochester
Primary completion
Sep 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
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.
10; 7; 8
SECONDARY
Percentage of Participants Without Disease Progression or Death at 12 Months
9; 6; 3
SECONDARY
Safety and Tolerability of Curcumin in Combination With Piperine
10; 7; 8

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.

Eligibility 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).
  • 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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04731844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search