Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00113841
First received: June 10, 2005
Last updated: November 15, 2011
Last verified: November 2011

June 10, 2005
November 15, 2011
November 2004
August 2009   (final data collection date for primary outcome measure)
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.
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
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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-kB and related genes in the Multiple Myeloma (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.

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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Curcumin
    2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)
  • Drug: Bioperine
    5 mg (Tablets) orally twice daily
  • Experimental: Curcumin
    Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.).
    Intervention: Drug: Curcumin
  • Experimental: Curcumin + Bioperine
    Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily.
    Interventions:
    • Drug: Curcumin
    • Drug: Bioperine
Not Provided

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

Inclusion Criteria:

  • 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.

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
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00113841
2003-0436
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Saroj Vadhan-Raj, MD MDAnderson Cancer Center
M.D. Anderson Cancer Center
November 2011

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