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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Curcumin Drug: Bioperine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
Study Start Date : November 2004
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Curcumin
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.).
 Drug: Curcumin
2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)
Experimental: Curcumin + Bioperine
Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily.
 Drug: Curcumin
2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)

Drug: Bioperine
5 mg (Tablets) orally twice daily


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113841


Locations
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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Saroj Vadhan-Raj, MD MDAnderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113841    
Other Study ID Numbers: 2003-0436
First Posted: June 13, 2005    Key Record Dates
Results First Posted: October 19, 2011
Last Update Posted: November 23, 2011
Last Verified: November 2011
Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Diferuloylmethane Derivative
Curcumin
Bioperine
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action