Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
Study Details
Study Description
Brief Summary
Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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. |
Outcome Measures
Primary Outcome Measures
- Participants Survival Status as of the Time of the Extension Study Follow-up [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 [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 [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) [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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).
Exclusion Criteria:
- 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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic - Scottsdale | Scottsdale | Arizona | United States | 85259 |
2 | Stanford University Cancer Center | Stanford | California | United States | 94305 |
3 | Cancer & Blood Disease Center | Lecanto | Florida | United States | 34461 |
4 | H. Lee Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
5 | Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | United States | 30060 |
6 | Hematology Oncology Associates of Illinois | Chicago | Illinois | United States | 60611 |
7 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
8 | University of Chicago | Chicago | Illinois | United States | 60637 |
9 | John Hopkins University Hospital | Baltimore | Maryland | United States | 21231 |
10 | Mayo Clinic - Rochester | Rochester | Minnesota | United States | 55905 |
11 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
12 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
13 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
14 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109-1024 |
15 | St. Johannes Hospital | Duisburg | Germany | D-47166 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Barry Skikne, MD, Celgene Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
- CC-5013-MDS-009
- CC-5013-MDS-003E
Study Results
Participant Flow
Recruitment Details | 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. |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | Lenalidomide |
---|---|
Arm/Group Description | 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. |
Period Title: MDS-003 Study | |
STARTED | 148 |
COMPLETED | 24 |
NOT COMPLETED | 124 |
Period Title: MDS-003 Study | |
STARTED | 54 |
Informed Consent Given | 33 |
Other Source of Follow-up Info Used | 21 |
COMPLETED | 54 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Lenalidomide |
---|---|
Arm/Group Description | 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. |
Overall Participants | 148 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
70.0
(10.50)
|
Sex: Female, Male (Count of Participants) | |
Female |
97
65.5%
|
Male |
51
34.5%
|
Region of Enrollment (participants) [Number] | |
United States |
112
75.7%
|
Germany |
36
24.3%
|
Outcome Measures
Title | Participants Survival Status as of the Time of the Extension Study Follow-up |
---|---|
Description | Count of participants who were alive or deceased at the time of the extension study follow-up. |
Time Frame | up to 7 years |
Outcome Measure Data
Analysis Population Description |
---|
Intent to treat population |
Arm/Group Title | Lenalidomide |
---|---|
Arm/Group Description | 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. |
Measure Participants | 148 |
Deceased |
101
68.2%
|
Alive |
29
19.6%
|
Unknown |
18
12.2%
|
Title | Kaplan Meier Estimate for Overall Survival |
---|---|
Description | 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. |
Time Frame | up to 7 years |
Outcome Measure Data
Analysis Population Description |
---|
Intent to treat population |
Arm/Group Title | Lenalidomide |
---|---|
Arm/Group Description | 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. |
Measure Participants | 148 |
Median (95% Confidence Interval) [months] |
39.47
|
Title | Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up |
---|---|
Description | Count of participants who progressed to AML at the time of the extension study follow-up. |
Time Frame | up to 7 years |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Lenalidomide |
---|---|
Arm/Group Description | 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. |
Measure Participants | 147 |
Progressed to AML |
36
24.3%
|
Did not progress to AML |
86
58.1%
|
Unknown |
25
16.9%
|
Title | Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML) |
---|---|
Description | 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. |
Time Frame | up to 7 years |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Lenalidomide |
---|---|
Arm/Group Description | 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. |
Measure Participants | 147 |
Median (95% Confidence Interval) [months] |
NA
|
Title | Cause of Death for Participants Who Died |
---|---|
Description | Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up. |
Time Frame | up to 7 years |
Outcome Measure Data
Analysis Population Description |
---|
Safety population of participants who died |
Arm/Group Title | Lenalidomide |
---|---|
Arm/Group Description | 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. |
Measure Participants | 101 |
Disease progression - AML |
24
16.2%
|
Disease progression - MDS |
7
4.7%
|
Infection - Sepsis |
9
6.1%
|
Infection - Respiratory |
4
2.7%
|
Infection - Infection (not specified) |
3
2%
|
Cardiac - Cardiac heart failure |
9
6.1%
|
Cardiac - Myocardial infarction |
3
2%
|
Cardiac - Sudden death |
1
0.7%
|
Hemorrhage - Cerebral hemorrhage |
3
2%
|
Hemorrhage - Gastrointestinal hemorrhage |
1
0.7%
|
Hemorrhage - Unknown origin |
1
0.7%
|
Neoplasm - Endometrial |
1
0.7%
|
Neoplasm - Lung Cancer |
1
0.7%
|
Neoplasm - Ovarian |
1
0.7%
|
Other Events - Multi-organ failure |
2
1.4%
|
Gastrointestinal - Intestinal perforation |
1
0.7%
|
Venous-thromboembolic - Pulmonary embolism |
1
0.7%
|
Others - Cause of death unknown |
29
19.6%
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | Adverse events not captured during the extension follow-up. See Study NCT00065156 for AEs during the MDS-003 study. | |
Arm/Group Title | Lenalidomide | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
Lenalidomide | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Lenalidomide | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
Lenalidomide | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Associate Director, Clinical Trials Disclosure |
---|---|
Organization | Celgene Corporation |
Phone | 1-888-260-1599 |
clinicaltrialdisclosure@celgene.com |
- CC-5013-MDS-009
- CC-5013-MDS-003E