Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151203
Status:
COMPLETED
Last Update Posted:
2021-05-27
First Post:
2005-09-06
Brief Title:
Phase II Study of Biaxin Revlimid and Dexamethasone for Untreated Multiple Myeloma
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Phase II Study of Clarithromycin Biaxin Lenalidomide Revlimid and Dexamethasone Decadron for Newly Diagnosed Subjects With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2021-05
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 STUDY OBJECTIVES
To evaluate the efficacy of the combination of clarithromycin Biaxin lenalidomide Revlimid and dexamethasone Decadron as an induction therapy for patients with newly diagnosed multiple myeloma MM
To evaluate the safety of the combination of clarithromycin lenalidomide and dexamethasone as an induction therapy for patients with newly diagnosed MM
SECONDARY STUDY OBJECTIVES
To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide
To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy
To evaluate the efficacy of the combination of clarithromycin Biaxin lenalidomide Revlimid and dexamethasone Decadron as an induction therapy for patients with newly diagnosed multiple myeloma MM
To evaluate the safety of the combination of clarithromycin lenalidomide and dexamethasone as an induction therapy for patients with newly diagnosed MM
SECONDARY STUDY OBJECTIVES
To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide
To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy
Detailed Description:
None
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