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

NCT01099267 | Completed Results DMC

• 2 other identifiers: CC-5013-MDS-009CC-5013-MDS-003E
• Study Type: observational
• Target: 54
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Myelodysplastic Syndrome

Keywords

MDS

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Celgene: lead

Study Sites (15)

Mayo Clinic - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Stanford University Cancer Center

Stanford, California, 94305, United States

Location

Cancer & Blood Disease Center

Lecanto, Florida, 34461, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

Hematology Oncology Associates of Illinois

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

John Hopkins University Hospital

Baltimore, Maryland, 21231, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

St. Johannes Hospital

Duisburg, D-47166, Germany

Location

Related Publications (2)

• Gohring G, Giagounidis A, Busche G, Hofmann W, Kreipe HH, Fenaux P, Hellstrom-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. doi: 10.3324/haematol.2010.026658. Epub 2010 Nov 25.

  PMID: 21109690 BACKGROUND

• List A, Dewald G, Bennett J, Giagounidis A, Raza A, Feldman E, Powell B, Greenberg P, Thomas D, Stone R, Reeder C, Wride K, Patin J, Schmidt M, Zeldis J, Knight R; Myelodysplastic Syndrome-003 Study Investigators. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. 2006 Oct 5;355(14):1456-65. doi: 10.1056/NEJMoa061292.

  PMID: 17021321 RESULT

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Barry Skikne, MD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 6, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 19, 2019
• Results First Posted: November 18, 2011

Record last verified: 2019-11

Locations

US (14); DE (1)