Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Prostate Cancer, Smoldering Multiple Myeloma (SMM)
Conditions
Keywords
curcumin, peperine, prostate cancer, Multiple Myeloma, Smoldering Multiple Myeloma (SMM), Monoclonal Gammopathy of Undetermined Significance (MGUS)
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.
Detailed description
The purpose of this study is to determine whether the supplement of curcumin plus peperine can prevent or delay the progression of prostate cancer, monoclonal gammopathy of unknown significant, or low-risk smoldering myeloma into a more aggressive cancer which requires treatment. The investigator will be evaluating a marker in patients blood called MIC-1 to determine whether it could be a useful predictor of whether the disease is improving or progressing.
Interventions
Curcumin with piperine is a well-tolerated over-the-counter supplement.
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From date of enrollment until the date of first documented response assessed up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Percentage of Participants Without Disease Progression or Death at 12 Months | From enrollment to 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrea Lipe
University of Rochester Wilmot Cancer Center
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 65.1 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 10 / 12 | 7 / 8 | 8 / 9 |
| serious Total, serious adverse events | 1 / 12 | 0 / 8 | 0 / 9 |
Outcome results
None listed