Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Treatment Closed Not specified Other 2003-0436 NCT00113841

Trial Description

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-B and related genes in the MM cells.

Further Study Information

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.

Before treatment starts, you will have a complete medical history and physical exam. You will have blood tests (about 1-2 tablespoons), a urine test, and bone marrow exam will be performed. To collect a bone marrow sample, an area of hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test.

The blood tests will be repeated every 2 to 4 weeks and then as needed (about 1-2 tablespoons). The bone marrow exams may be done after 4 weeks and 12 weeks of treatment and as needed. MRI and/or bone x-rays will be performed as appropriate.

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. Both of the study agents are available commercially but will be provided free of charge.

Eligibility Criteria

Inclusion Criteria:

• Patients with multiple myeloma who are asymptomatic and without serious or imminent complications.

• Adequate hematologic, renal, and hepatic functions.

• 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Saroj Vadhan-Raj, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00113841
Information obtained from ClinicalTrials.gov on July 16, 2008