Ignite Creation Date:
2024-05-05 @ 11:15 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01283997
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2011-01-25
Brief Title:
Prevention of Treatment Induced Neuropathy in Multiple Myeloma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Minocycline vs Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2024-06
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:
The goal of this clinical research study is to see if Minocin minocycline can help to control nerve damage that causes numbness and tingling in the hands and feet neuropathy in patients receiving thalidomide andor bortezomib
Detailed Description:
Neuropathy is one of the side effects that occurs in some patients who receive thalidomide andor bortezomib Usually it is mild and sometimes improves or goes away when the thalidomide or bortezomib treatment is stopped However in some patients the numbness and tingling remains even after the treatment is stopped It can make it difficult for patients to feel objects with their hands or to feel the ground under their feet This can lead to difficulty with tasks such as buttoning clothes or writing as well as difficulty walking
Minocycline is designed to help prevent inflammation of the nerves which can stop the nerve cells from dying
If you are found to be eligible to take part in this study you will be randomly assigned as in the flip of a coin to 1 of 2 groups Participants in the 2 groups will receive standard education from the study staff about the signs and symptoms of neuropathy If you are assigned to Group A you will take a placebo pills that look like the study drug but do not contain any active ingredients once on Day 1 Staring on Day 2 you will take the pills 2 times a day every 12 hours for 10 weeks If you are assigned to Group B you will take a larger dose of minocycline 1 time by mouth on the day you start therapy on this study and then a smaller dose of minocycline by mouth every 12 hours for 10 weeks Minocycline can be taken with or without food but it needs to be taken with liquid No matter which group you are assigned to you will receive thalidomide andor bortezomib according to the standard schedule Neither you nor your doctor nor any of the clinic or research staff will know which medication placebo or minocycline you are receiving Only the pharmacist who gives you the medication will know If there is any serious concern for your safety because of the medication you might be receiving your doctor will be told which medication you are receiving
Study Visits
One 1 time a week during Weeks 1-9 you will complete the symptom questionnaire This questionnaire may be done in person or by phone
Before you begin each new cycle of multiple myeloma therapy for 10 weeks the following tests and procedures will be performed
You will have a physical exam
Your complete medical history will be recorded and you will be asked about any drugs you may be taking
Your performance status will be recorded
Blood about 2-3 teaspoons will be drawn for routine tests
Blood about 4 teaspoons will be drawn to test for certain cytokines
You will have a nerve function test
You will complete the questionnaire that has questions about unusual sensations you may experience in your arms legs hands and feet and problems these sensations may cause for you
You will complete the symptom questionnaire that has questions about pain fatigue nausea disturbed sleep difficulty remembering mood work and enjoyment of life
You will complete a questionnaire that asks about high likely you are to doze off or fall asleep while doing certain activities This should take about 2-3 minutes
You will be asked about any side effects you may have experienced
End-of-Study Visit
Once you have completed the study medication minocycline or placebo after Week 10 you will be asked to return for an end-of-study visit
You will have a physical exam
Your complete medical history will be recorded and you will be asked about any drugs you may be taking
Your performance status will be recorded
Blood about 2-3 teaspoons will be drawn for routine tests
Blood about 4 teaspoons will be drawn to test for certain cytokines
You will have a nerve function test and a neuro-cognitive test
You will complete the questionnaire that has questions about unusual sensations you may experience in your arms legs hands and feet and problems these sensations may cause for you
You will complete the symptom questionnaire that has questions about pain fatigue nausea disturbed sleep difficulty remembering mood work and enjoyment of life
You will complete a questionnaire that asks about high likely you are to doze off or fall asleep while doing certain activities This should take about 2-3 minutes
You will be asked about any side effects you may have experienced
If intolerable side effects occur or if thalidomide andor bortezomib for the myeloma is stopped you will be taken off study
This is an investigational study Minocycline is commercially available and FDA approved for use in other diseases such as infections caused by bacteria Minocycline is not FDA approved for the treatment of neuropathy In neuropathy it is currently being used in research only Up to 142 patients will take part in this study All will be enrolled at MD Anderson
Minocycline is designed to help prevent inflammation of the nerves which can stop the nerve cells from dying
If you are found to be eligible to take part in this study you will be randomly assigned as in the flip of a coin to 1 of 2 groups Participants in the 2 groups will receive standard education from the study staff about the signs and symptoms of neuropathy If you are assigned to Group A you will take a placebo pills that look like the study drug but do not contain any active ingredients once on Day 1 Staring on Day 2 you will take the pills 2 times a day every 12 hours for 10 weeks If you are assigned to Group B you will take a larger dose of minocycline 1 time by mouth on the day you start therapy on this study and then a smaller dose of minocycline by mouth every 12 hours for 10 weeks Minocycline can be taken with or without food but it needs to be taken with liquid No matter which group you are assigned to you will receive thalidomide andor bortezomib according to the standard schedule Neither you nor your doctor nor any of the clinic or research staff will know which medication placebo or minocycline you are receiving Only the pharmacist who gives you the medication will know If there is any serious concern for your safety because of the medication you might be receiving your doctor will be told which medication you are receiving
Study Visits
One 1 time a week during Weeks 1-9 you will complete the symptom questionnaire This questionnaire may be done in person or by phone
Before you begin each new cycle of multiple myeloma therapy for 10 weeks the following tests and procedures will be performed
You will have a physical exam
Your complete medical history will be recorded and you will be asked about any drugs you may be taking
Your performance status will be recorded
Blood about 2-3 teaspoons will be drawn for routine tests
Blood about 4 teaspoons will be drawn to test for certain cytokines
You will have a nerve function test
You will complete the questionnaire that has questions about unusual sensations you may experience in your arms legs hands and feet and problems these sensations may cause for you
You will complete the symptom questionnaire that has questions about pain fatigue nausea disturbed sleep difficulty remembering mood work and enjoyment of life
You will complete a questionnaire that asks about high likely you are to doze off or fall asleep while doing certain activities This should take about 2-3 minutes
You will be asked about any side effects you may have experienced
End-of-Study Visit
Once you have completed the study medication minocycline or placebo after Week 10 you will be asked to return for an end-of-study visit
You will have a physical exam
Your complete medical history will be recorded and you will be asked about any drugs you may be taking
Your performance status will be recorded
Blood about 2-3 teaspoons will be drawn for routine tests
Blood about 4 teaspoons will be drawn to test for certain cytokines
You will have a nerve function test and a neuro-cognitive test
You will complete the questionnaire that has questions about unusual sensations you may experience in your arms legs hands and feet and problems these sensations may cause for you
You will complete the symptom questionnaire that has questions about pain fatigue nausea disturbed sleep difficulty remembering mood work and enjoyment of life
You will complete a questionnaire that asks about high likely you are to doze off or fall asleep while doing certain activities This should take about 2-3 minutes
You will be asked about any side effects you may have experienced
If intolerable side effects occur or if thalidomide andor bortezomib for the myeloma is stopped you will be taken off study
This is an investigational study Minocycline is commercially available and FDA approved for use in other diseases such as infections caused by bacteria Minocycline is not FDA approved for the treatment of neuropathy In neuropathy it is currently being used in research only Up to 142 patients will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-00247 | REGISTRY | None | None |
| 1P01CA124787-01 | NIH | NCI CTRP | httpsreporternihgovquickSearch1P01CA124787-01 |