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

NCT ID: NCT00113841

Last Updated: 2011-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2009-08-31

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Diferuloylmethane Derivative; Curcumin; Bioperine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Curcumin

Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.).

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

2 grams (Capsules) orally in 2 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.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)

Bioperine

Intervention Type: DRUG

5 mg (Tablets) orally twice daily

Interventions

Curcumin

2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)

Intervention Type: DRUG

Bioperine

5 mg (Tablets) orally twice daily

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saroj Vadhan-Raj, MD

Role: PRINCIPAL_INVESTIGATOR

MDAnderson Cancer Center

Locations

U.T.M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

The University of Texas M.D.Anderson Cancer Center

Other Identifiers

2003-0436

Identifier Type: -

Identifier Source: org_study_id