Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113841
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2005-06-10
Brief Title:
Curcumin Diferuloylmethane Derivative With or Without Bioperine in Patients With Multiple Myeloma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pilot Study of Curcumin Diferuloylmethane Derivative With or Without Bioperine in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None