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
Enrollment
15
Locations
7
Actual Duration (Months)
3.6
Patients Per Site
0.5
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase

    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

    ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Mayo Clinic - ScottsdaleScottsdaleArizonaUnited States85259
    2Stanford University Cancer CenterStanfordCaliforniaUnited States94305
    3Cancer & Blood Disease CenterLecantoFloridaUnited States34461
    4H. Lee Moffitt Cancer CenterTampaFloridaUnited States33612
    5Northwest Georgia Oncology Centers, P.C.MariettaGeorgiaUnited States30060
    6Hematology Oncology Associates of IllinoisChicagoIllinoisUnited States60611
    7Rush University Medical CenterChicagoIllinoisUnited States60612
    8University of ChicagoChicagoIllinoisUnited States60637
    9John Hopkins University HospitalBaltimoreMarylandUnited States21231
    10Mayo Clinic - RochesterRochesterMinnesotaUnited States55905
    11Memorial Sloan-Kettering Cancer CenterNew YorkNew YorkUnited States10065
    12Wake Forest UniversityWinston-SalemNorth CarolinaUnited States27157
    13The Cleveland Clinic FoundationClevelandOhioUnited States44195
    14Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States98109-1024
    15St. Johannes HospitalDuisburgGermanyD-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 DetailsThis 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 DetailWhen 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 TitleLenalidomide
    Arm/Group DescriptionNo 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
    STARTED148
    COMPLETED24
    NOT COMPLETED124
    Period Title: MDS-003 Study
    STARTED54
    Informed Consent Given33
    Other Source of Follow-up Info Used21
    COMPLETED54
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleLenalidomide
    Arm/Group DescriptionNo 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 Participants148
    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
    TitleParticipants Survival Status as of the Time of the Extension Study Follow-up
    DescriptionCount of participants who were alive or deceased at the time of the extension study follow-up.
    Time Frameup to 7 years

    Outcome Measure Data

    Analysis Population Description
    Intent to treat population
    Arm/Group TitleLenalidomide
    Arm/Group DescriptionNo 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 Participants148
    Deceased
    101
    68.2%
    Alive
    29
    19.6%
    Unknown
    18
    12.2%
    2. Primary Outcome
    TitleKaplan Meier Estimate for Overall Survival
    DescriptionOverall 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 Frameup to 7 years

    Outcome Measure Data

    Analysis Population Description
    Intent to treat population
    Arm/Group TitleLenalidomide
    Arm/Group DescriptionNo 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 Participants148
    Median (95% Confidence Interval) [months]
    39.47
    3. Primary Outcome
    TitleParticipants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up
    DescriptionCount of participants who progressed to AML at the time of the extension study follow-up.
    Time Frameup 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 TitleLenalidomide
    Arm/Group DescriptionNo 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 Participants147
    Progressed to AML
    36
    24.3%
    Did not progress to AML
    86
    58.1%
    Unknown
    25
    16.9%
    4. Primary Outcome
    TitleKaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)
    DescriptionProgression 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 Frameup 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 TitleLenalidomide
    Arm/Group DescriptionNo 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 Participants147
    Median (95% Confidence Interval) [months]
    NA
    5. Primary Outcome
    TitleCause of Death for Participants Who Died
    DescriptionSummary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.
    Time Frameup to 7 years

    Outcome Measure Data

    Analysis Population Description
    Safety population of participants who died
    Arm/Group TitleLenalidomide
    Arm/Group DescriptionNo 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 Participants101
    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 TitleLenalidomide
    Arm/Group DescriptionNo 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
    Total0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Lenalidomide
    Affected / at Risk (%)# Events
    Total0/0 (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/TitleAssociate Director, Clinical Trials Disclosure
    OrganizationCelgene Corporation
    Phone1-888-260-1599
    Emailclinicaltrialdisclosure@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