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Trial record 43 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia (AML)

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

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ClinicalTrials.gov Identifier: NCT01099267
Recruitment Status : Completed
First Posted : April 6, 2010
Results First Posted : November 18, 2011
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Study Type Observational
Study Design Time Perspective: Retrospective
Condition Myelodysplastic Syndrome
Enrollment 54
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 Details 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
Hide 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 [1]
Completed 24
Not Completed 124
Reason Not Completed
Adverse Event             37
Lack of Efficacy             52
Withdrawal by Subject             8
Lost to Follow-up             1
Death             11
Study Closed by Sponsor             2
Disease Progression             7
Investigator Decision             2
Non-Compliance             2
Loss of Response             1
Secondary Malign Disease             1
[1]
This information duplicates results in NCT00065156.
Period Title: MDS-009 Extension Follow-up
Started 54 [1]
Informed Consent Given 33
Other Source of Follow-up Info Used 21 [2]
Completed 54
Not Completed 0
[1]
Participants from MDS-003 (including some who did not complete) at sites participating in MDS-009.
[2]
Social Security Death Index, public records, verbal reports from health providers and next of kin.
Arm/Group Title Lenalidomide
Hide 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 Number of Baseline Participants 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants
70.0  (10.50)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants
Female
97
  65.5%
Male
51
  34.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
United States 112
Germany 36
1.Primary Outcome
Title Participants Survival Status as of the Time of the Extension Study Follow-up
Hide Description Count of participants who were alive or deceased at the time of the extension study follow-up.
Time Frame up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Lenalidomide
Hide 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 Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: participants
Deceased 101
Alive 29
Unknown 18
2.Primary Outcome
Title Kaplan Meier Estimate for Overall Survival
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Lenalidomide
Hide 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 Number of Participants Analyzed 148
Median (95% Confidence Interval)
Unit of Measure: months
39.47
(32.99 to 47.14)
3.Primary Outcome
Title Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up
Hide Description Count of participants who progressed to AML at the time of the extension study follow-up.
Time Frame up to 7 years
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: participants
Progressed to AML 36
Did not progress to AML 86
Unknown 25
4.Primary Outcome
Title Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 147
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Not evaluable as 50% of participants in MDS-003 did not progress to AML.
5.Primary Outcome
Title Cause of Death for Participants Who Died
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants who died
Arm/Group Title Lenalidomide
Hide 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 Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: participants
Disease progression - AML 24
Disease progression - MDS 7
Infection - Sepsis 9
Infection - Respiratory 4
Infection - Infection (not specified) 3
Cardiac - Cardiac heart failure 9
Cardiac - Myocardial infarction 3
Cardiac - Sudden death 1
Hemorrhage - Cerebral hemorrhage 3
Hemorrhage - Gastrointestinal hemorrhage 1
Hemorrhage - Unknown origin 1
Neoplasm - Endometrial 1
Neoplasm - Lung Cancer 1
Neoplasm - Ovarian 1
Other Events - Multi-organ failure 2
Gastrointestinal - Intestinal perforation 1
Venous-thromboembolic - Pulmonary embolism 1
Others - Cause of death unknown 29
Time Frame [Not Specified]
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
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01099267     History of Changes
Other Study ID Numbers: CC-5013-MDS-009
CC-5013-MDS-003E ( Other Identifier: Celgene )
First Submitted: April 5, 2010
First Posted: April 6, 2010
Results First Submitted: October 5, 2011
Results First Posted: November 18, 2011
Last Update Posted: December 12, 2016