Multiple Myeloma Clinical Trial
Official title:
Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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