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


N/A
N/A
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment

Outcome Description:

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.

Outcome Time Frame:

Baseline through 4 weeks of treatment

Safety Issue:

No

Principal Investigator

Saroj Vadhan-Raj, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MDAnderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2003-0436

NCT ID:

NCT00113841

Start Date:

November 2004

Completion Date:

August 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Diferuloylmethane Derivative
  • Curcumin
  • Bioperine
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
U.T.M.D. Anderson Cancer Center Houston, Texas  77030