NCT00113841

Brief Summary

Primary Objectives:

  1. 1.To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma.
  2. 2.To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable multiple-myeloma

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 19, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

4.8 years

First QC Date

June 10, 2005

Results QC Date

September 13, 2011

Last Update Submit

November 15, 2011

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaDiferuloylmethane DerivativeCurcuminBioperine

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline through 4 weeks of treatment

Study Arms (2)

Curcumin

EXPERIMENTAL

Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.).

Drug: Curcumin

Curcumin + Bioperine

EXPERIMENTAL

Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily.

Drug: CurcuminDrug: Bioperine

Interventions

CurcuminDRUG

2 grams (Capsules) orally in 2 divided doses (a.m., p.m.)

CurcuminCurcumin + Bioperine
BioperineDRUG

5 mg (Tablets) orally twice daily

Curcumin + Bioperine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
Saroj Vadhan-Raj, MD/Professor
Organization
UT MD Anderson Cancer Center
xzhou@mdanderson.org
713-792-9660

Study Officials

  • Saroj Vadhan-Raj, MD

    MDAnderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2005

First Posted

June 13, 2005

Study Start

November 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

November 23, 2011

Results First Posted

October 19, 2011

Record last verified: 2011-11

Locations

US(1)