Myelodysplastic SyndromeNCT01099267
Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
An observational study of Myelodysplastic Syndrome, run by Celgene at 15 sites in 2 countries.
Trial summary
Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- Type of treatment
- Pill or oral medicine
- How many people
- 54 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 1 Mar 2010to 1 Oct 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects Previously Enrolled in Celgene Protocol NCT00065156 (CC-5013-MDS-003)
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
John Hopkins University Hospital
Baltimore, Maryland, 21231
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Cancer & Blood Disease Center
Lecanto, Florida, 34461
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Stanford University Cancer Center
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
- Conditions
- Myelodysplastic Syndrome
- Keywords
- MDS
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study start1 Mar 2010
- Primary completion1 Oct 2010
- Study completion1 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Skikne, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099267
- Sponsor's protocol ID
- CC-5013-MDS-009
- Other IDs
- CC-5013-MDS-003E
- Status last verified
- Nov 2019
- First submitted
- 5 Apr 2010
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21109690List 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.
PubMed 17021321
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
- ClinicalTrials.gov ID
- NCT01099267
- Acronym / sponsor ID
- CC-5013-MDS-009
- Conditions
- Myelodysplastic Syndrome
- Keywords
- MDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 1 Oct 2010 (actual)
- Study completion
- 1 Oct 2010 (actual)
- First posted
- 6 Apr 2010 (estimated)
- Results
- Posted 18 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects Previously Enrolled in Celgene Protocol NCT00065156 (CC-5013-MDS-003)
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants Survival Status as of the Time of the Extension Study Follow-up
Time frame: up to 7 years
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
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
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
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
Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21109690Gohring 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.
- Results publication: PubMed 17021321List 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Skikne, MD study director
Celgene Corporation
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome, run by Celgene at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Survival Status as of the Time of the Extension Study Follow-up (time frame: up to 7 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01099267, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.