Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
- To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma.
- To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.
- To evaluate the biologic effects of curcumin alone and in combination with Bioperine on the expression of NF-kB and related genes in the Multiple Myeloma (MM) cells.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma|
- Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment [ Time Frame: Baseline through 4 weeks of treatment ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2004|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.).
2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)
Experimental: Curcumin + Bioperine
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily.
2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)Drug: Bioperine
5 mg (Tablets) orally twice daily
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. Bioperine is a pepper extract that increases the absorption of nutrient supplements.
In this study, 6 patients at a time will be randomly assigned (as in the toss of a coin) to one of two groups of 3 patients each. One group (Arm A) will receive curcumin alone. The other group (Arm B) will receive curcumin in combination with Bioperine. There is an equal chance of being in either group. While on study you may receive standard supportive care as appropriate.
Both of the study agents will be taken by mouth two times a day. Each group will have five dose levels of curcumin, starting with the lowest dose. After 6 patients have been enrolled in the first level (3 in each arm), the next group will be treated at a new dose level. You will always receive the same dose during your treatment, which will continue for at least 12 weeks unless there is evidence that the disease has gotten worse or intolerable side effects occur. You may receive treatment up to one year depending on your response to treatment.
You may be treated as outpatient and may receive your treatment at home. You will be asked to return to M. D. Anderson every 4 weeks for evaluation and physical exam.
This is an investigational study. A total of up to 30 evaluable patients will take part in the study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113841
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Saroj Vadhan-Raj, MD||MDAnderson Cancer Center|