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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT01099267
Collaborator
(none)
54
15
7
3.6
0.5

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

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
    Actual Study Start Date :
    Mar 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Oct 1, 2010

    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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.

    2. 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:
    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).

    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

    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT01099267
    Other Study ID Numbers:
    • CC-5013-MDS-009
    • CC-5013-MDS-003E
    First Posted:
    Apr 6, 2010
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019
    Keywords provided by Celgene
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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%
    2. Primary Outcome
    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
    3. Primary Outcome
    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%
    4. Primary Outcome
    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
    5. Primary Outcome
    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

    [Not Specified]

    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
    Email clinicaltrialdisclosure@celgene.com
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT01099267
    Other Study ID Numbers:
    • CC-5013-MDS-009
    • CC-5013-MDS-003E
    First Posted:
    Apr 6, 2010
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019