Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01099267
First received: April 5, 2010
Last updated: November 30, 2011
Last verified: November 2011
Results First Received: October 5, 2011  
Study Type: Observational
Study Design: Time Perspective: Retrospective
Condition: Myelodysplastic Syndrome

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   MDS-003 Study
    Lenalidomide  
STARTED     148 [1]
COMPLETED     24  
NOT COMPLETED     124  
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 2:   MDS-009 Extension Follow-up
    Lenalidomide  
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.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Lenalidomide  
Number of Participants  
[units: participants]
  148  
Age  
[units: years]
Mean ± Standard Deviation
  70.0  ± 10.50  
Gender  
[units: participants]
 
Female     97  
Male     51  
Region of Enrollment  
[units: participants]
 
United States     112  
Germany     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participants Survival Status as of the Time of the Extension Study Follow-up   [ Time Frame: up to 7 years ]

2.  Primary:   Kaplan Meier Estimate for Overall Survival   [ Time Frame: up to 7 years ]

3.  Primary:   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 ]

4.  Primary:   Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)   [ Time Frame: up to 7 years ]

5.  Primary:   Cause of Death for Participants Who Died   [ Time Frame: up to 7 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


No publications provided by Celgene Corporation

Publications automatically indexed to this study:

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01099267     History of Changes
Other Study ID Numbers: CC-5013-MDS-009, CC-5013-MDS-003E
Study First Received: April 5, 2010
Results First Received: October 5, 2011
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices