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
  Purpose

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


Condition
Myelodysplastic Syndrome

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • 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.


Enrollment: 54
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099267

Locations
United States, Arizona
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
United States, Florida
Cancer & Blood Disease Center
Lecanto, Florida, United States, 34461
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
United States, Illinois
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
John Hopkins University Hospital
Baltimore, Maryland, United States, 21231
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Germany
St. Johannes Hospital
Duisburg, Germany, D-47166
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Barry Skikne, MD Celgene Corporation
  More Information

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01099267     History of Changes
Other Study ID Numbers: CC-5013-MDS-009, CC-5013-MDS-003E
Study First Received: April 5, 2010
Results First Received: October 5, 2011
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Celgene Corporation:
MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014