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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00113841 |
Purpose
Primary Objectives:
| Condition | Intervention |
|---|---|
|
Multiple Myeloma |
Drug: Curcumin Drug: Bioperine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma |
| Enrollment: | 42 |
| Study Start Date: | November 2004 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Curcumin: Experimental |
Drug: Curcumin
2 Grams (Capsules) By Mouth Twice Daily
|
| Curcumin + Bioperine: Experimental |
Drug: Curcumin
2 Grams (Capsules) By Mouth Twice Daily
Drug: Bioperine
5 mg (Tablets) By Mouth 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.
Before treatment starts, you will have a complete medical history and physical exam. You will have blood tests (about 1-2 tablespoons), a urine test, and bone marrow exam will be performed. To collect a bone marrow sample, an area of hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test.
The blood tests will be repeated every 2 to 4 weeks and then as needed (about 1-2 tablespoons). The bone marrow exams may be done after 4 weeks and 12 weeks of treatment and as needed. MRI and/or bone x-rays will be performed as appropriate.
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Saroj Vadhan-Raj, MD | MDAnderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor ) |
| Study ID Numbers: | 2003-0436 |
| Study First Received: | June 10, 2005 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00113841 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma Diferuloylmethane Derivative Curcumin Bioperine |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Immunoproliferative Disorders Neoplasms by Histologic Type |
Curcumin Immune System Diseases Hematologic Diseases Vascular Diseases Enzyme Inhibitors Pharmacologic Actions Multiple Myeloma Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents Central Nervous System Agents Neoplasms, Plasma Cell |
