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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
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE June 10, 2005
First Posted Date  ICMJE June 13, 2005
Results First Submitted Date  ICMJE September 13, 2011
Results First Posted Date  ICMJE October 19, 2011
Last Update Posted Date November 23, 2011
Study Start Date  ICMJE November 2004
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
To evaluate clinical tolerance and safety in the two arms: curcumin versus curcumin plus Bioperine
Change History Complete list of historical versions of study NCT00113841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
Official Title  ICMJE Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
Brief Summary

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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Curcumin
    2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)
  • Drug: Bioperine
    5 mg (Tablets) orally twice daily
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2009)
42
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
24
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00113841
Other Study ID Numbers  ICMJE 2003-0436
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saroj Vadhan-Raj, MD MDAnderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date November 2011

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