Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182663
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2005-09-15
Brief Title:
Thalidomide Dexamethasone and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Maintenance Therapy With Thalidomide Dexamethasone and Clarithromycin Biaxin Following AutologousSyngeneic Transplant for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This phase II trial studies the side effects and how well giving thalidomide dexamethasone and clarithromycin together works in treating patients with multiple myeloma previously treated with transplant Biological therapies such as thalidomide and clarithromycin may stimulate the immune system in different ways and stop cancer cells from growing Dexamethasone also works in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving thalidomide together with dexamethasone and clarithromycin after a transplant may be an effective treatment for multiple myeloma
Detailed Description:
OBJECTIVES
I Evaluate the toxicity of the use of ThalidomideBiaxin ClarithromycinDexamethasone as maintenance therapy after autologoussyngeneic transplant
II Evaluate the median time to disease progression III Evaluate survival
OUTLINE
Patients receive thalidomide orally PO once daily QD dexamethasone PO once weekly and clarithromycin PO twice daily BID Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I Evaluate the toxicity of the use of ThalidomideBiaxin ClarithromycinDexamethasone as maintenance therapy after autologoussyngeneic transplant
II Evaluate the median time to disease progression III Evaluate survival
OUTLINE
Patients receive thalidomide orally PO once daily QD dexamethasone PO once weekly and clarithromycin PO twice daily BID Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-00387 | REGISTRY | CTRP Clinical Trial Reporting Program | None |