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Study Summary
No. 2003-0436:.......Myeloma......Saroj Vadhan-Raj......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:		2003-0436
Study Title:Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients with Multiple Myeloma
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Physician New Patient Referral
Name:Saroj Vadhan-RajPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7966
Contact us about clinical trials
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General Information
Disease Group:MyelomaSupported By:Sabinsa Corporation
Phase of Study:N/AReturn
Visit:		Every 4 weeks.
Treatment
Agents:		Bioperine
Curcumin		Home Care:Curcumin and Bioperine are both in pill form, therefore, could be taken orally
at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		None for the treatment
Description/
Intervention:		The goal of this clinical research study is to compare curcumin alone to
curcumin given in combination with Bioperine in the treatment of multiple
myeloma. The safety of these two treatments and how the disease responds will
also be compared.
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Study Objectives / Outcomes
(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.
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Study Status Information
Study Activation / Registration Date:11/03/2004
IRB Review and Approval Date:07/02/2003
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Multiple myeloma patients who have been previously untreated, are asymptomatic and without serious or imminent complications, have relapsed or failed treatment with conventional treatment or progressed on no or limited maintenance, or are in stable partial remission.

2) Bone marrow plasma cells >/= 10% and serum M-protein level >/= 0.5 g/dL and/or urinary Bence Jones protein >/= 100 mg/24 hr. When the bone marrow (BM) plasma cell differential is <10% on aspirate smears, the % of clonal plasma cells by using plasma cell markers (Kappa/lambda or CD138+ cells) by IHC methods will be acceptable.

3) Adequate hematologic findings (ANC > 1000/mm^3, platelet count > 100,000/mm^3, Hgb > 10 gms/dL), renal (serum creatinene < 2.0 mg/dL), and hepatic (serum bilirubin < 2.0 mg/dL: SGOT or SGPT < 3 x upper limit of normal) functions.

4) Signed informed consent form.

5) ECOG P S of 0-2.

6) Life expectancy of >/= 6 months.

7) Effective means of contraception for women of child bearing potential.

8) Women of child-bearing potential must have a negative pregnancy test.

9) Ability to comply with study visit schedule and protocol requirements.
Exclusion Criteria:1) Pregnant or lactating women.

2) Previously untreated patients with high tumor mass, symptomatic or impending fractures, hypercalcemia or plasma cell leukemia.

3) Patients with benign monoclonal gammopathy (MGUS) or non-secretory multiple myeloma.

4) Significant cardiac disease, dysarrhythmia, or recent H/O MI or ischemia.

5) Comorbid condition which renders patients at high risk of treatment complications.

6) History of significant neurological or psychiatric disorders including dementia or seizures that would impede consent, treatment or follow-up.

7) H/O curcumin or Bioperine supplement in prior 4 weeks.

8) Patients on anti-convulsants, anti-coagulant treatment, or anti-arrhythmic medications for cardiac arrhythmia other than atrial fibrillation.
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