TriangleNCT04731844 · STUDY IN CONTEXT
Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- trial label
- Curcumin and Piperine in Patients on Surveillance for Monoclonal Gammopathy, Smoldering Myeloma or Prostate Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 3
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0000
- source section id
- NCT04731844-om-0000
- source outcome index
- 0
- endpoint
- 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.
- endpoint definition
- 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.
- time origin
- From date of enrollment until the date of first documented response assessed up to 12 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0001
- source section id
- NCT04731844-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants Without Disease Progression or Death at 12 Months
- endpoint definition
- 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.
- time origin
- From enrollment to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0002
- source section id
- NCT04731844-om-0002
- source outcome index
- 2
- endpoint
- Safety and Tolerability of Curcumin in Combination With Piperine
- endpoint definition
- 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.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Prostate Cancer
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Smoldering Multiple Myeloma (SMM)
- regimen
- 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.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Monoclonal Gammopathy of Unknown Significance (MGUS)
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Prostate Cancer
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Smoldering Multiple Myeloma (SMM)
- regimen
- 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.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Monoclonal Gammopathy of Unknown Significance (MGUS)
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Prostate Cancer
- regimen
- 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.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Smoldering Multiple Myeloma (SMM)
- regimen
- 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.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Monoclonal Gammopathy of Unknown Significance (MGUS)
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04731844-om-0002#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- harm key
- EG000
- source section id
- NCT04731844-ae
- event group key
- EG000
- event group label
- Prostate Cancer
- serious affected
- 1
- serious at risk
- 12
- other affected
- 10
- other at risk
- 12
- frequency threshold
- 0
- collection period
- 1 year
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- harm key
- EG001
- source section id
- NCT04731844-ae
- event group key
- EG001
- event group label
- Smoldering Multiple Myeloma (SMM)
- serious affected
- 0
- serious at risk
- 8
- other affected
- 7
- other at risk
- 8
- frequency threshold
- 0
- collection period
- 1 year
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT04731844
- harm key
- EG002
- source section id
- NCT04731844-ae
- event group key
- EG002
- event group label
- Monoclonal Gammopathy of Unknown Significance (MGUS)
- serious affected
- 0
- serious at risk
- 9
- other affected
- 8
- other at risk
- 9
- frequency threshold
- 0
- collection period
- 1 year
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice