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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00065156 |
Purpose
This study is a multicenter, single-arm, open-label study of oral CC-5013 monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of CC-5013 treatment. Subjects will receive CC-5013 in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) 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
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Drug: CC-5013 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects With Myelodysplastic Syndromes Associated With a Del (5q) Cytogenetic Abnormality. |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2003 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: CC-5013
lenalidomide 5-mg capsules for oral administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 32 Study Locations
More Information
| Responsible Party: | Celgene Corporation ( Deborah Ingenito ) |
| Study ID Numbers: | CC-5013-MDS-003 |
| Study First Received: | July 17, 2003 |
| Last Updated: | May 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00065156 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
MDS CC-5013 Revlimid Celgene |
|
Disease Precancerous Conditions Hematologic Diseases Antineoplastic Agents Myelodysplastic Syndromes Lenalidomide Pharmacologic Actions Preleukemia |
Neoplasms Pathologic Processes Therapeutic Uses Syndrome Chromosome Aberrations Congenital Abnormalities Bone Marrow Diseases |