Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065156
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2003-07-17
Brief Title:
Lenalidomide SafetyEfficacy in Myelodysplastic Syndromes MDS Associated With a Deletion Del5q Cytogenetic Abnormality
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Multicenter Single-arm Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del5q Cytogenetic Abnormality
Status:
COMPLETED
Status Verified Date:
2019-11
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 study is a multicenter single-arm open-label study of oral lenalidomide monotherapy administered to red blood cell RBC transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes MDS associated with a del 5q31-33 cytogenetic abnormality Screening procedures will take place within 28 days of the first day of lenalidomide treatment Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles or until bone marrow disease progression or progressionrelapse following erythroid hematologic improvement is documented Study visits will occur every cycle every 28 days and laboratory monitoring to assess hematological parameters will occur every 14 days Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments
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