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
Results First Received: September 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Curcumin
Drug: Bioperine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: 11/2004 to 1/2008. All participants were recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 42 patients enrolled, 9 were excluded from the trial prior to group assignment because of screen failure.

Reporting Groups
  Description
Curcumin Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
Curcumin + Bioperine Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily

Participant Flow:   Overall Study
    Curcumin     Curcumin + Bioperine  
STARTED     16     17  
COMPLETED     15     15  
NOT COMPLETED     1     2  
Disease progression                 0                 2  
Non-compliant                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Curcumin Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
Curcumin + Bioperine Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
Total Total of all reporting groups

Baseline Measures
    Curcumin     Curcumin + Bioperine     Total  
Number of Participants  
[units: participants]
  16     17     33  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 46 to 78 )  
  62  
  ( 41 to 78 )  
  59  
  ( 41 to 78 )  
Gender  
[units: participants]
     
Female     6     5     11  
Male     10     12     22  
Region of Enrollment  
[units: participants]
     
United States     16     17     33  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Saroj Vadhan-Raj, MD/Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-9660
e-mail: xzhou@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113841     History of Changes
Other Study ID Numbers: 2003-0436
Study First Received: June 10, 2005
Results First Received: September 13, 2011
Last Updated: November 15, 2011
Health Authority: United States: Food and Drug Administration