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NCT00065156 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
NCT00065156 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 148 participants.
The verdict
NCT00065156, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
Study 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 progression/relapse 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.
Interventions
- DRUG lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2003-06-01 |
| Est. Completion | 2008-08-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00065156
The ClinicalTrials.gov registry entry for NCT00065156 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lenalidomide is the first listed.
NCT00065156 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00065156 about?
NCT00065156 is a clinical study titled "Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality". 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 procedure...
What is the current status of trial NCT00065156?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2003-06-01. Estimated completion is 2008-08-01.
What interventions are being tested in trial NCT00065156?
The interventions under investigation include: lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00065156?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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