Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00113841|
Recruitment Status : Completed
First Posted : June 13, 2005
Results First Posted : October 19, 2011
Last Update Posted : November 23, 2011
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- 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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Curcumin Drug: Bioperine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
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.)
5 mg (Tablets) orally twice daily
- 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 ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with multiple myeloma who have been previously untreated, are asymptomatic and without serious or imminent complications; or have relapsed or failed treatment with conventional therapy.
- Adequate hematologic, renal, and hepatic functions.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Previously untreated patients with high tumor mass; symptomatic or impending fractures.
- Patients with significant cardiac disease.
- Patients with comorbid condition which renders patients at high risk of treatment complications.
- History of significant neurological or psychiatric disorders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
|First Posted:||June 13, 2005 Key Record Dates|
|Results First Posted:||October 19, 2011|
|Last Update Posted:||November 23, 2011|
|Last Verified:||November 2011|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action