Trial Outcomes & Findings for Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003 (NCT NCT01099267)
NCT ID: NCT01099267
Last Updated: 2019-11-19
Results Overview
Count of participants who were alive or deceased at the time of the extension study follow-up.
Recruitment status
COMPLETED
Target enrollment
54 participants
Primary outcome timeframe
up to 7 years
Results posted on
2019-11-19
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
MDS-003 Study
STARTED
|
148
|
|
MDS-003 Study
COMPLETED
|
24
|
|
MDS-003 Study
NOT COMPLETED
|
124
|
|
MDS-009 Extension Follow-up
STARTED
|
54
|
|
MDS-009 Extension Follow-up
Informed Consent Given
|
33
|
|
MDS-009 Extension Follow-up
Other Source of Follow-up Info Used
|
21
|
|
MDS-009 Extension Follow-up
COMPLETED
|
54
|
|
MDS-009 Extension Follow-up
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
MDS-003 Study
Adverse Event
|
37
|
|
MDS-003 Study
Lack of Efficacy
|
52
|
|
MDS-003 Study
Withdrawal by Subject
|
8
|
|
MDS-003 Study
Lost to Follow-up
|
1
|
|
MDS-003 Study
Death
|
11
|
|
MDS-003 Study
Study Closed by Sponsor
|
2
|
|
MDS-003 Study
Disease Progression
|
7
|
|
MDS-003 Study
Investigator Decision
|
2
|
|
MDS-003 Study
Non-Compliance
|
2
|
|
MDS-003 Study
Loss of Response
|
1
|
|
MDS-003 Study
Secondary Malign Disease
|
1
|
Baseline Characteristics
Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=148 Participants
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.
|
|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 7 yearsPopulation: Intent to treat population
Count of participants who were alive or deceased at the time of the extension study follow-up.
Outcome measures
| Measure |
Lenalidomide
n=148 Participants
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.
|
|---|---|
|
Participants Survival Status as of the Time of the Extension Study Follow-up
Deceased
|
101 participants
|
|
Participants Survival Status as of the Time of the Extension Study Follow-up
Alive
|
29 participants
|
|
Participants Survival Status as of the Time of the Extension Study Follow-up
Unknown
|
18 participants
|
PRIMARY outcome
Timeframe: up to 7 yearsPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Lenalidomide
n=148 Participants
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.
|
|---|---|
|
Kaplan Meier Estimate for Overall Survival
|
39.47 months
Interval 32.99 to 47.14
|
PRIMARY outcome
Timeframe: up to 7 yearsPopulation: 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.
Count of participants who progressed to AML at the time of the extension study follow-up.
Outcome measures
| Measure |
Lenalidomide
n=147 Participants
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.
|
|---|---|
|
Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up
Progressed to AML
|
36 participants
|
|
Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up
Did not progress to AML
|
86 participants
|
|
Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up
Unknown
|
25 participants
|
PRIMARY outcome
Timeframe: up to 7 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Lenalidomide
n=147 Participants
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.
|
|---|---|
|
Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)
|
NA months
Not evaluable as 50% of participants in MDS-003 did not progress to AML.
|
PRIMARY outcome
Timeframe: up to 7 yearsPopulation: Safety population of 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.
Outcome measures
| Measure |
Lenalidomide
n=101 Participants
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.
|
|---|---|
|
Cause of Death for Participants Who Died
Disease progression - AML
|
24 participants
|
|
Cause of Death for Participants Who Died
Disease progression - MDS
|
7 participants
|
|
Cause of Death for Participants Who Died
Infection - Sepsis
|
9 participants
|
|
Cause of Death for Participants Who Died
Infection - Respiratory
|
4 participants
|
|
Cause of Death for Participants Who Died
Infection - Infection (not specified)
|
3 participants
|
|
Cause of Death for Participants Who Died
Cardiac - Cardiac heart failure
|
9 participants
|
|
Cause of Death for Participants Who Died
Cardiac - Myocardial infarction
|
3 participants
|
|
Cause of Death for Participants Who Died
Cardiac - Sudden death
|
1 participants
|
|
Cause of Death for Participants Who Died
Hemorrhage - Cerebral hemorrhage
|
3 participants
|
|
Cause of Death for Participants Who Died
Hemorrhage - Gastrointestinal hemorrhage
|
1 participants
|
|
Cause of Death for Participants Who Died
Hemorrhage - Unknown origin
|
1 participants
|
|
Cause of Death for Participants Who Died
Neoplasm - Endometrial
|
1 participants
|
|
Cause of Death for Participants Who Died
Neoplasm - Lung Cancer
|
1 participants
|
|
Cause of Death for Participants Who Died
Neoplasm - Ovarian
|
1 participants
|
|
Cause of Death for Participants Who Died
Other Events - Multi-organ failure
|
2 participants
|
|
Cause of Death for Participants Who Died
Gastrointestinal - Intestinal perforation
|
1 participants
|
|
Cause of Death for Participants Who Died
Venous-thromboembolic - Pulmonary embolism
|
1 participants
|
|
Cause of Death for Participants Who Died
Others - Cause of death unknown
|
29 participants
|
Adverse Events
Lenalidomide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER