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 on June 10, 2005. Last Updated on November 15, 2011 History of Changes

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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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

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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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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