Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352794
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2006-07-14
Brief Title:
Lenalidomide for Patients With Myelofibrosis MF
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of Lenalidomide CC-5013 and Prednisone as a Therapy for Patients With Myelofibrosis MF
Status:
COMPLETED
Status Verified Date:
2019-07
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 learn if lenalidomide in combination with prednisone can help to control myelofibrosis The safety of lenalidomide and prednisone for the treatment of myelofibrosis will also be studied
Detailed Description:
Lenalidomide is designed to change the bodys immune system It may also interfere with the development of tiny blood vessels that help support tumor growth Therefore in theory it may decrease or prevent the growth of cancer cells Prednisone is designed to improve the results of lenalidomide and to help reduce the side effects
If you are found to be eligible to take part in this study you will take 1-2 capsules of lenalidomide by mouth daily You will take lenalidomide daily for 21 days followed by 1 week rest This 28-day period is called a study cycle
Swallow lenalidomide capsules whole with water at the same time each day Do not break chew or open the capsules
If you miss a dose of lenalidomide take it as soon as you remember on the same day If you miss taking your dose for the entire day take your regular dose the next scheduled day do NOT take double your regular dose to make up for the missed dose
You will take prednisone by mouth every day during Cycles 1-2 and every other day during Cycle 3 You may only take prednisone for Cycles 1-3
You will be given a study drug diary In this diary you will record when you take the study drugs
During treatment blood about 1 tablespoon will be drawn once every 1-2 weeks Following the completion of 24 cycles blood about 1 tablespoon will be drawn every 1- 3 months The tests may be repeated more frequently to check for side effects
Every month for the first 3 months and then every 3 months until you complete 24 cycles you will have a study visit You will have a bone marrow biopsyaspirate every 3 months Lenalidomide will be provided to you as a monthly 28-day supply
Following the completion of Cycle 24 you will have a study visit every 6 months You will have a bone marrow biopsyaspirate every 12 months Lenalidomide will be provided to you as a monthly 28-day supply
Depending on side effects and the activity of the study drug against the disease your dose of the study drug may be increased or decreased
You may stay on study for as long as you are benefitting You will be taken off study if you are not or are no longer benefitting or intolerable side effects occur
This is an investigational study Lenalidomide and prednisone are both FDA approved and commercially available Lenalidomide is approved by the Food and Drug Administration FDA for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy Myelodysplastic syndrome MDS and Multiple Myeloma MM are cancers of the blood It is currently being tested in a variety of cancer conditions In this case it is considered experimental Prednisone is on the market for many different things but not specifically for Myelofibrosis The use of these drugs in combination is considered investigational in this study Up to 41 patients will take part in this study All will be enrolled at M D Anderson
If you are found to be eligible to take part in this study you will take 1-2 capsules of lenalidomide by mouth daily You will take lenalidomide daily for 21 days followed by 1 week rest This 28-day period is called a study cycle
Swallow lenalidomide capsules whole with water at the same time each day Do not break chew or open the capsules
If you miss a dose of lenalidomide take it as soon as you remember on the same day If you miss taking your dose for the entire day take your regular dose the next scheduled day do NOT take double your regular dose to make up for the missed dose
You will take prednisone by mouth every day during Cycles 1-2 and every other day during Cycle 3 You may only take prednisone for Cycles 1-3
You will be given a study drug diary In this diary you will record when you take the study drugs
During treatment blood about 1 tablespoon will be drawn once every 1-2 weeks Following the completion of 24 cycles blood about 1 tablespoon will be drawn every 1- 3 months The tests may be repeated more frequently to check for side effects
Every month for the first 3 months and then every 3 months until you complete 24 cycles you will have a study visit You will have a bone marrow biopsyaspirate every 3 months Lenalidomide will be provided to you as a monthly 28-day supply
Following the completion of Cycle 24 you will have a study visit every 6 months You will have a bone marrow biopsyaspirate every 12 months Lenalidomide will be provided to you as a monthly 28-day supply
Depending on side effects and the activity of the study drug against the disease your dose of the study drug may be increased or decreased
You may stay on study for as long as you are benefitting You will be taken off study if you are not or are no longer benefitting or intolerable side effects occur
This is an investigational study Lenalidomide and prednisone are both FDA approved and commercially available Lenalidomide is approved by the Food and Drug Administration FDA for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy Myelodysplastic syndrome MDS and Multiple Myeloma MM are cancers of the blood It is currently being tested in a variety of cancer conditions In this case it is considered experimental Prednisone is on the market for many different things but not specifically for Myelofibrosis The use of these drugs in combination is considered investigational in this study Up to 41 patients will take part in this study All will be enrolled at M D 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