Trial Outcomes & Findings for Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer (NCT NCT04731844)
NCT ID: NCT04731844
Last Updated: 2026-05-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From date of enrollment until the date of first documented response assessed up to 12 months
Results posted on
2026-05-12
Participant Flow
A total of 30 participants provided informed consent and considered enrolled. Due to withdrawal of consent by one enrolled participant prior to assignment to a treatment arm/group, there are only N=29 assigned to a treatment group after consent. This number (n=29)is reflected in the participant flow.
Participant milestones
| Measure |
Prostate Cancer
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
9
|
|
Overall Study
COMPLETED
|
9
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
6
|
Reasons for withdrawal
| Measure |
Prostate Cancer
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
4
|
Baseline Characteristics
Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer
Baseline characteristics by cohort
| Measure |
Prostate Cancer
n=12 Participants
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
n=8 Participants
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
n=9 Participants
Curcumin plus Piperine at a dose of 4 gram/5mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
16 Participants
n=99 Participants
|
|
Age, Continuous
|
68.3 Years
n=1512 Participants
|
62.5 Years
n=504 Participants
|
63.4 Years
n=2016 Participants
|
65.1 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=1512 Participants
|
7 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
28 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=1512 Participants
|
8 participants
n=504 Participants
|
9 participants
n=2016 Participants
|
29 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment until the date of first documented response assessed up to 12 monthsPopulation: All enrolled participants
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.
Outcome measures
| Measure |
Prostate Cancer
n=12 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
n=8 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
n=9 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
|---|---|---|---|
|
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 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 12 monthsPopulation: All enrolled participants
Proportion of participants who remained free from disease progression or death from any cause at 12 months after enrollment. Participants without documented progression or death by 12 months were considered progression-free.
Outcome measures
| Measure |
Prostate Cancer
n=12 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
n=8 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
n=9 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
|---|---|---|---|
|
Percentage of Participants Without Disease Progression or Death at 12 Months
|
9 participants
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 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.Population: All enrolled participants
Adverse events were summarized by grade and event type per CTCAE version 5.0. The safety population included all participants who received at least one dose of curcumin plus piperine. Results are presented as the number (percentage) of participants who experienced at least one adverse event.
Outcome measures
| Measure |
Prostate Cancer
n=12 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
n=8 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
n=9 Participants
Curcumin plus Piperine at a dose of 2gm/10mg (2 tablets) orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
|---|---|---|---|
|
Safety and Tolerability of Curcumin in Combination With Piperine
|
10 participants
|
7 participants
|
8 participants
|
Adverse Events
Prostate Cancer
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Smoldering Multiple Myeloma (SMM)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Monoclonal Gammopathy of Unknown Significance (MGUS)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prostate Cancer
n=12 participants at risk
Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
n=8 participants at risk
Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
n=9 participants at risk
Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
|---|---|---|---|
|
Gastrointestinal disorders
Esophageal perforation
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
Other adverse events
| Measure |
Prostate Cancer
n=12 participants at risk
Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Smoldering Multiple Myeloma (SMM)
n=8 participants at risk
Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
Monoclonal Gammopathy of Unknown Significance (MGUS)
n=9 participants at risk
Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months
Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
22.2%
2/9 • 1 year
|
|
Investigations
Alanine Aminotransferase increased
|
0.00%
0/12 • 1 year
|
37.5%
3/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
2/12 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
11.1%
1/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
11.1%
1/9 • 1 year
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
22.2%
2/9 • 1 year
|
|
Investigations
Creatinine Increased
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • 1 year
|
25.0%
2/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Edema Limbs
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Endocrine disorders
Endocrine Disorders-Other, specify
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Eye Disorders-Other, specify
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Fatigue
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
22.2%
2/9 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Disorder -Other, Specify
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
11.1%
1/9 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other, specify
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other,Specify
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
Urinary Frequency
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Infections and Infestations-Other,Specify
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Vascular disorders
Thromboembolic Event
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
16.7%
2/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Injury, poisoning and procedural complications
Injury,poisoning and procedural complication-Other,specify
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-Other,specify
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • 1 year
|
12.5%
1/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Nervous system disorder-Other, specify
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
11.1%
1/9 • 1 year
|
|
General disorders
Pain
|
0.00%
0/12 • 1 year
|
12.5%
1/8 • 1 year
|
22.2%
2/9 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
11.1%
1/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorder-Other, specify
|
0.00%
0/12 • 1 year
|
0.00%
0/8 • 1 year
|
11.1%
1/9 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
11.1%
1/9 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
urinary retention
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
Urinary Urgency
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
|
Cardiac disorders
Sinus Tachycardia
|
8.3%
1/12 • 1 year
|
0.00%
0/8 • 1 year
|
0.00%
0/9 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place