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Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
This study has been completed.
Study NCT00113841   Information provided by M.D. Anderson Cancer Center
First Received: June 10, 2005   Last Updated: August 11, 2009   History of Changes

June 10, 2005
August 11, 2009
November 2004
August 2009   (final data collection date for primary outcome measure)
To study the clinical tolerance and safety in the two arms: Curcumin versus Curcumin plus Bioperine. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
To evaluate clinical tolerance and safety in the two arms: curcumin versus curcumin plus Bioperine
Complete list of historical versions of study NCT00113841 on ClinicalTrials.gov Archive Site
 
 
 
Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma

Primary Objectives:

  1. To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma.
  2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.
  3. To evaluate the biologic effects of curcumin alone and in combination with Bioperine on the expression of NF-B and related genes in the MM cells.

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 To collect a bone marrow sample, an area of hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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.

 
Interventional
Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Multiple Myeloma
  • Drug: Curcumin
  • Drug: Bioperine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
42
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with multiple myeloma who are asymptomatic and without serious or imminent complications.
  • Adequate hematologic, renal, and hepatic functions.
  • ECOG performance status 0, 1, or 2.

Exclusion Criteria:

  • 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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00113841
Saroj Vadhan-Raj, MD/Professor, U.T.M.D. Anderson Cancer Center
2003-0436
M.D. Anderson Cancer Center
 
Principal Investigator: Saroj Vadhan-Raj, MD MDAnderson Cancer Center
M.D. Anderson Cancer Center
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP