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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01099267
First received: April 5, 2010
Last updated: November 30, 2011
Last verified: November 2011

April 5, 2010
November 30, 2011
March 2010
October 2010   (final data collection date for primary outcome measure)
  • Participants Survival Status as of the Time of the Extension Study Follow-up [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
    Count of participants who were alive or deceased at the time of the extension study follow-up.
  • Kaplan Meier Estimate for Overall Survival [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
    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.
  • Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
    Count of participants who progressed to AML at the time of the extension study follow-up.
  • Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML) [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
    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.
  • Cause of Death for Participants Who Died [ Time Frame: up to 7 years ] [ Designated as safety issue: Yes ]
    Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.
  • Overall survival/vital status of CC-5013-MDS-003 subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Acute Myeloid Leukemia (AML) progression of CC-5013-MDS-003 subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01099267 on ClinicalTrials.gov Archive Site
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Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003

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

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Subjects Previously Enrolled in Celgene Protocol NCT00065156 (CC-5013-MDS-003)

Myelodysplastic Syndrome
Not Provided
Lenalidomide
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.
Göhring G, Giagounidis A, Büsche G, Hofmann W, Kreipe HH, Fenaux P, Hellström-Lindberg E, Schlegelberger B. Cytogenetic follow-up by karyotyping and fluorescence in situ hybridization: implications for monitoring patients with myelodysplastic syndrome and deletion 5q treated with lenalidomide. Haematologica. 2011 Feb;96(2):319-22. Epub 2010 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.
  2. 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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01099267
CC-5013-MDS-009, CC-5013-MDS-003E
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Barry Skikne, MD Celgene Corporation
Celgene Corporation
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP