Pilot Study of Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients with Multiple Myeloma
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.
Disease Group: Myeloma
Treatment Agent: Bioperine
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: None for the treatment
Return Visit: Every 4 weeks.
Home Care: Curcumin and Bioperine are both in pill form, therefore, could be taken orally ;at home.
(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.
IRB Review and Approval Date: JUL 2,2003
Recruitment Status: Not Accepting
Projected Accrual: N/A
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.
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.