Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003

Study Overview
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Brief Summary
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Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).

Official Title
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Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003

Conditions
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Myelodysplastic Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study. Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (i.e. next of kin, legal representative) will be obtained prior to collection of data). Exclusion Criteria: 1. Consent refused for any reason at current or long-term follow up completed in 2007 (long-term follow up: survival data collection completed to obtain further safety information on CC-5013-MDS-003 discontinued subjects from May - October 2007).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lenalidomide<br>No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Survival Status as of the Time of the Extension Study Follow-up | Count of participants who were alive or deceased at the time of the extension study follow-up. | up to 7 years | 
| Kaplan Meier Estimate for Overall Survival | Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up. | up to 7 years | 
| Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up | Count of participants who progressed to AML at the time of the extension study follow-up. | up to 7 years | 
| Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML) | Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up. | up to 7 years | 
| Cause of Death for Participants Who Died | Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up. | up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS