N/A
Completed N=33
Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT00113841 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment — 21; 37 Percent reduction — p=0.16
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-kB and related genes in the Multiple Myeloma (MM) cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment |
21; 37 | 0.16 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00113841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.