Trial Outcomes & Findings for Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma (NCT NCT00113841)
NCT ID: NCT00113841
Last Updated: 2011-11-23
Results Overview
Percent change of NF-kB =\[(expression at 4 weeks- expression at baseline)/expression at baseline\]\*100%. Bone marrow aspirate/biopsy for expression of NF-kB and related genes/proteins markers at baseline and after 4 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Baseline through 4 weeks of treatment
Results posted on
2011-11-23
Participant Flow
Recruitment period: 11/2004 to 1/2008. All participants were recruited at UT MD Anderson Cancer Center.
Of 42 patients enrolled, 9 were excluded from the trial prior to group assignment because of screen failure.
Participant milestones
| Measure |
Curcumin
Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
|
Curcumin + Bioperine
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Curcumin
Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
|
Curcumin + Bioperine
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
|
|---|---|---|
|
Overall Study
Disease progression
|
0
|
2
|
|
Overall Study
Non-compliant
|
1
|
0
|
Baseline Characteristics
Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Curcumin
n=16 Participants
Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
|
Curcumin + Bioperine
n=17 Participants
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59 years
n=5 Participants
|
62 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 4 weeks of treatmentPopulation: All participants in the two arms (Curcumin versus Curcumin plus Bioperine) who received at least 4 weeks of treatment were eligible for outcome evaluation.
Percent change of NF-kB =\[(expression at 4 weeks- expression at baseline)/expression at baseline\]\*100%. Bone marrow aspirate/biopsy for expression of NF-kB and related genes/proteins markers at baseline and after 4 weeks.
Outcome measures
| Measure |
Curcumin
n=15 Participants
Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
|
Curcumin + Bioperine
n=15 Participants
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
|
|---|---|---|
|
Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment
|
21 Percent reduction
Standard Deviation 37
|
37 Percent reduction
Standard Deviation 25
|
Adverse Events
Curcumin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Curcumin + Bioperine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Curcumin
n=16 participants at risk
Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
|
Curcumin + Bioperine
n=17 participants at risk
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
|
|---|---|---|
|
Gastrointestinal disorders
Appetite decreased
|
0.00%
0/16 • 4 years and 2 months
|
5.9%
1/17 • 4 years and 2 months
|
|
Eye disorders
Burning in the eyes
|
0.00%
0/16 • 4 years and 2 months
|
5.9%
1/17 • 4 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • 4 years and 2 months
|
11.8%
2/17 • 4 years and 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
Eye disorders
Redness of eyes
|
0.00%
0/16 • 4 years and 2 months
|
5.9%
1/17 • 4 years and 2 months
|
|
Eye disorders
Watering eyes
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
Gastrointestinal disorders
Feeling of fullness with capsules
|
0.00%
0/16 • 4 years and 2 months
|
11.8%
2/17 • 4 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • 4 years and 2 months
|
11.8%
2/17 • 4 years and 2 months
|
|
General disorders
Flushing
|
12.5%
2/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
General disorders
Headache
|
12.5%
2/16 • 4 years and 2 months
|
23.5%
4/17 • 4 years and 2 months
|
|
Gastrointestinal disorders
Indigestion
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
6.2%
1/16 • 4 years and 2 months
|
5.9%
1/17 • 4 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
Gastrointestinal disorders
Queasy feeling
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
General disorders
Yellow discoloration of finger tips
|
12.5%
2/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
General disorders
Yellow discoloration of sweat
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
|
General disorders
Yellow discoloration of urine
|
6.2%
1/16 • 4 years and 2 months
|
5.9%
1/17 • 4 years and 2 months
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • 4 years and 2 months
|
0.00%
0/17 • 4 years and 2 months
|
Additional Information
Saroj Vadhan-Raj, MD/Professor
UT MD Anderson Cancer Center
Phone: 713-792-9660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place