Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478777
Status:
COMPLETED
Last Update Posted:
2011-11-03
First Post:
2007-05-23
Brief Title:
A Multicenter Single-Arm Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Sponsor:
Celgene Corporation
Organization:
Celgene
Study Overview
Official Title:
A Multicenter Single-Arm Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-09
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 was a multicenter open-label single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone
This study CC-5013-MM-019 was set up and executed primarily as an expanded access program in Germany
Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 baseline with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1 Randomization blinding and stratification were not applied in this open-label single-arm study
Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles
Lenalidomide hard capsules was to be administered orally PO at a dose of 25 mg daily QD for the first 21 days of each 28-day cycle According to the protocol accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany
Upon discontinuation from study minimal information was collected in order to identify when disease progressed
This study CC-5013-MM-019 was set up and executed primarily as an expanded access program in Germany
Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 baseline with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1 Randomization blinding and stratification were not applied in this open-label single-arm study
Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles
Lenalidomide hard capsules was to be administered orally PO at a dose of 25 mg daily QD for the first 21 days of each 28-day cycle According to the protocol accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany
Upon discontinuation from study minimal information was collected in order to identify when disease progressed
Detailed Description:
None
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 |
|---|---|---|---|
| 2006-004532-73 | EUDRACT_NUMBER | None | None |