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| ID | Type | Description | Link |
|---|---|---|---|
| CC-5013-MDS-003E | Other Identifier | Celgene |
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Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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Inclusion Criteria:
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).
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Subjects Previously Enrolled in Celgene Protocol NCT00065156 (CC-5013-MDS-003)
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| Name | Affiliation | Role |
|---|---|---|
| Barry Skikne, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| Stanford University Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21109690 | Background | 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. | |
| 17021321 |
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When the final MDS-003 clinical study report was written, 76 participants had died; therefore, 72 of all 148 participants who first enrolled in the MDS-003 study could have been included in the extension study. Sixteen did not participate because their investigative sites did not participant. Two withdrew consent during the earlier study.
This extension study was conducted specifically to provide further long-term outcomes as regards overall survival/vital status and the possible occurrence of progression to AML for all participants previously enrolled in study NCT00065156 (Celgene CC-5013-MDS-003). Participants from the original study are included in the Participant Flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| MDS-003 Study |
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| Stanford |
| California |
| 94305 |
| United States |
| Cancer & Blood Disease Center | Lecanto | Florida | 34461 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | 30060 | United States |
| Hematology Oncology Associates of Illinois | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| John Hopkins University Hospital | Baltimore | Maryland | 21231 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| St. Johannes Hospital | Duisburg | D-47166 | Germany |
| Result |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| MDS-009 Extension Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | 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. | Intent to treat population | Posted | Number | participants | up to 7 years |
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| Primary | 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. | Intent to treat population | Posted | Median | 95% Confidence Interval | months | up to 7 years |
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| Primary | 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. | Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis. | Posted | Number | participants | up to 7 years |
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| Primary | 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. | Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis. | Posted | Median | 95% Confidence Interval | months | up to 7 years |
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| Primary | 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. | Safety population of participants who died | Posted | Number | participants | up to 7 years |
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Adverse events not captured during the extension follow-up. See Study NCT00065156 for AEs during the MDS-003 study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | 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. | 0 | 0 | 0 | 0 |
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Unless approved by Celgene, single center data will not be published before multicenter data, unless more than 1 year has elapsed since completion of the Study. Thereafter, Investigator may publish single center data provided that Investigator shall: i) provide a copy of the publication to Celgene at least 60 days in advance of submission for publication; ii) delete Celgene Confidential Information and; iii) delay submission up to 90 additional days to permit intellectual property filings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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