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Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

Sponsor
Celgene Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00064974
Collaborator
(none)
215
Enrollment
119
Locations
1
Arm
44.1
Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
215 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Feb 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: CC-5013

CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)

Drug: CC-5013
CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Other Names:
  • lenalidomide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. RBC Transfusion Independence []

    Secondary Outcome Measures

    1. ≥ 50% decrease in RBC transfusion requirement []

    2. Platelet Response []

      Platelet Response

    3. Neutrophil Response []

      Neutrophil Response

    4. Bone marrow Response []

      Bone marrow Response

    5. Duration of Response []

      Duration of Response

    6. Hemoglobin concentration []

      Change of hemoglobin concentration from baseline

    7. Number of Participants with Adverse Event []

      Number of Participants with Adverse Event

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must understand and voluntarily sign an informed consent form.

    • Age ≥ 18 years at the time of signing the informed consent form.

    • Must be able to adhere to the study visit schedule and other protocol requirements.

    • Diagnosis of low - or intermediate-1-risk IPSS (Appendix III) MDS without an abnormality of chromosome 5 involving a deletion between bands q31 and q33.

    • Red blood cell (RBC) transfusion-dependent anemia defined as having received ≥ to 2 units of RBCs within 8 weeks of the first day of study drug treatment.

    • Eastern Cooperative Oncology Group (ECOG) (Appendix IV) performance status score of 0, 1, or 2.

    • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.

    • Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

    • WCBP must agree to have pregnancy tests every 4 weeks while on study drug.

    Exclusion Criteria:

    • Pregnant or lactating females.

    • Prior therapy with lenalidomide.

    • An abnormality of chromosome 5 involving a deletion between bands q31 and q33.

    • Lab Abnormality: Absolute neutrophil count (ANC) <500 cells/mm3 (0.5 x 109/L)

    • Lab Abnormality: Platelet count <50,000/mm3 (50 x 109/L)

    • Lab Abnormality: Serum creatinine >2.5 mg/dL (221 mmol/L)

    • Lab Abnormality: Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) >3.0 x upper limit of normal (ULN)

    • Lab Abnormality: Serum total bilirubin >2.0 mg/dL (34 mmol/L)

    • Prior ≥ grade 3 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Appendix VI) allergic reaction/hypersensitivity to thalidomide.

    • Prior ≥ grade 3 NCI CTC (Appendix VI) rash or any desquamation (blistering) while taking thalidomide.

    • Clinically significant anemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding

    • If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be

    20 % and serum ferritin not less than 50 ng/mL.

    • Use of hematopoietic growth factors within 7 days of the first day of study drug treatment.

    • Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisone) within 28 days of the first day of study drug treatment.

    • Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study drug treatment.

    • Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for greater than or equal to 3 years.

    • Use of any other experimental therapy within 28 days of the first day of study drug treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Scottsdale Arizona United States 85258
    2 Mayo Clinic Scottsdale Arizona United States 85259
    3 Arizona Cancer Center Tucson Arizona United States 85724-5024
    4 Alta Bates Cancer Center Berkeley California United States 94704
    5 Desert Hematology Oncology Medical Group, Inc. Rancho Mirage California United States 92270
    6 Stanford University Medical Center Stanford California United States 94305-5750
    7 Florida Cancer Specialists Fort Myers Florida United States 33901
    8 Mayo Clinic Jacksonville Florida United States 32224
    9 Cancer & Blood Disease Center Lecanto Florida United States 34461
    10 University of Miami- Sylvester Comp Cancer Center Miami Florida United States 33136
    11 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    12 Northwest Georgia Oncology - Wellstar Cancer Research Marietta Georgia United States 30060
    13 Rush Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612-3515
    14 University of Chicago Medical Center Chicago Illinois United States 60637-1470
    15 Midwest Cancer Research Group Skokie Illinois United States 60077
    16 Indiana University Medical Center Indianapolis Indiana United States 46202-5149
    17 Johns Hopkins Oncology Center Baltimore Maryland United States 21287-8963
    18 Dana-Farber Cancer Institute Boston Massachusetts United States 02115-6084
    19 Wayne State University School of Medicine Detroit Michigan United States 48201-2097
    20 St. Luke's Oncology and Hematology Associates Duluth Minnesota United States 55805
    21 Mayo Clinic Rochester Minnesota United States 55905
    22 University of Nebraska Medical Center Omaha Nebraska United States 68198-7680
    23 Roswell Park Cancer Institute Buffalo New York United States 14263
    24 Winthrop University Hospital Mineola New York United States 11501-3893
    25 St. Vincents Comprehensive Cancer Center New York New York United States 10011
    26 New York Hospital- Cornell New York New York United States 10021-0034
    27 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    28 Mt. Sinai Medical Center New York New York United States 10029
    29 University of Rochester-James P. Wilmot Cancer Center Rochester New York United States 14642
    30 Wake Forest University School of Medicine Winston Salem North Carolina United States 27157-1082
    31 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    32 Oregon Health & Science University Portland Oregon United States 97201
    33 Kaiser Permanente Northwest Region Portland Oregon United States 97227
    34 Drexel University College of Medicine Philadelphia Pennsylvania United States 19129
    35 Western Pennsylvania Cancer Institute Pittsburgh Pennsylvania United States 15224
    36 MD Anderson Cancer Center Houston Texas United States 77030
    37 Swedish Cancer Institute Seattle Washington United States 98104
    38 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-4417
    39 Royal Adelaide Hospital - SA Pathology Haematology Adelaide South Australia Australia 5000
    40 Princess Alexandra Hospital - Haematology Brisbane Australia 4102
    41 Royal Prince Alfred Hospital - Institute of Haematology Camperdown Australia 2050
    42 Peter McCallum Cancer Institute - Directorate of Cancer Medecine East Melbourne Australia 3002
    43 Frankston Hospital-peninsula Health - Oncology Day Unit Frankston Australia 3199
    44 The Alfred Hospital - malignant haematology & stem cell transplantation Melbourne Australia 3004
    45 Calvary Mater Newcastle - Haematology Waratah Australia 2298
    46 Border Medical Oncology Wodonga Australia 3690
    47 Wollongong Hospital - Haematology Wollongong Australia 2500
    48 UZ Gent - Hematology Gent Belgium 9000
    49 University Hospital Leuven - Hematology Leuven Belgium 3000
    50 Cliniques Universitaires ULC de Mont-Godinne - Hematology Yvoir Belgium 5530
    51 Fakultní nemocnice Hradec Králové - Hematology Hradec Kralove Czech Republic 50005
    52 Charles university Hospital - Internal Medicine Prague Czech Republic 12808
    53 Aalborg Sygemus - Haematology Aalborg Denmark 9000
    54 Aarhus University Hospital Aarhus Denmark 8000
    55 Odense University Hospital Odense Denmark 5000
    56 Vejle Hospital - Hematology Vejle Denmark 7100
    57 CHU Angers - Service des maladies du sang Angers France 49033
    58 Centre Hospitalier de la côte basque - Hematologie Bayonne France 64019
    59 Centre Hospitalier Départemental Vendée - Onco-hematologie La Roche sur Yon France 85925
    60 CHRU de Lille - Service des maladies du sang Lille France cedex 59037
    61 Institut Paoli Calmette - Hematology 1 Marseille France cedex 13009
    62 CHU Hôtel-Dieu - Hematologie Nantes France cedex 01 44093
    63 Hôpital Saint Louis - Immuno-hematologie Paris France 75010
    64 CHU Saint Antoine - Service des maladies du sang Paris France cedex 12 75012
    65 CHRU - Hôpital du Haut Lévêque - Centre François Magendie Pessac France 33604
    66 Centre Hospitalier Lyon sud - Hematologie Pierre-Benite France cedex 69495
    67 CHRU Hôpital Purpan - Hematologie Toulouse France cedex 9 31059
    68 Hôpital Bretonneau - Hématologie & Thérapie cellulaire Tours France cedex 37044
    69 CHU Nancy - Hematologie Vandoeuvre-les-Nancy France 54511
    70 Universitätsklinikum Essen, Klinik für Hämatologie Essen Germany 45122
    71 Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V Heidelberg Germany 69120
    72 Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie Jena Germany 7740
    73 Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II Leipzig Germany 4103
    74 Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A Münster Germany 48149
    75 Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II Tübingen Germany 72076
    76 Universitätsklinikum Ulm - Klinik fur Innere Medizin III Ulm Germany 89081
    77 Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II Würzburg Germany 97080
    78 University of Athens - Alexandra Hospital; Clinical Therapeutics Athens Greece 14572
    79 Università degli Studi di Bologna - Policlinico S. Orsola - Hematology Bologna Italy 40138
    80 AO Universitaria San Martino - hematooncology Genova Italy 16132
    81 Fondazione "G. Pascale" - Hematology Napoli Italy 80131
    82 Ospedale San Luigi AO Luigi Gonzaga - Hematology Orbassano Italy 10043
    83 Universita degli Studi di Padova - Clinical & Experimental Medicine Padova Italy 35128
    84 Ospedale Guglielmo da Saliceto - hematooncology Piacenza Italy 29100
    85 Unità di Ematologia Arcispedale S. Maria Nuova - Haematology Reggio Emilia Italy 42100
    86 Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology Roma Italy 00161
    87 A.O.U. San Giovanni Battista - Hematology Torino Italy 10126
    88 VUMC - Hematology Amsterdam Netherlands 1081 HV
    89 Erasmus Medical Center - Hematology Rotterdam Netherlands 3015 CE
    90 University Medical Center - Hematology Utrecht Netherlands 3584-CX
    91 Medical Sciences - Hematology & BMT Moscow Russian Federation 125167
    92 Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology Moscow Russian Federation 125284
    93 Russian Research Institute of Hematology and Blood Transfusion - Hematology St. Petersburg Russian Federation 191024
    94 State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology St. Petersburg Russian Federation 197341
    95 Hospital Germans Trias i Pujol - Hematology Badalona Spain 8916
    96 Hospital Clinic i Provincial de Barcelona - Hematology Barcelona Spain 08036
    97 Hospital de Donostia - Hematology Guipúzcoa Spain 20014
    98 Hospital de La Princesa - Hematology Madrid Spain 28006
    99 Hospital 12 de Octubre - Hematology Madrid Spain 28041
    100 Hospital de Salamanca - Hematology Salamanca Spain 37007
    101 Hospital Universitario Marqués de Valdecilla - Hematology Santander Spain 39008
    102 Hospital La Fe - Hematology Valencia Spain 46009
    103 Sahlgrenska Hospital, University of Goteborg - Hematology Goteborg Sweden S-41345
    104 Karolinska University Hospital Huddinge - Center of hematology Stockholm Sweden 14152
    105 Karolinska University Hospital Solna- medicine Stockholm Sweden 17176
    106 Overlakare Medocomcentrum - Hematology Uppsala Sweden 75185
    107 Inselspital, Institut für Medizinische Onkologie Bern Switzerland 3010
    108 Hôpitaux Universitaire de Genève - Oncologie Genève Switzerland 1211
    109 Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich Zurich Switzerland 8091
    110 Royal Bournemouth Hospital - Haematology Bournemouth United Kingdom BH7 7DW
    111 St James's University Hospital - Haematology Leeds United Kingdom LS9 7TF
    112 St Bartholomew's Hospital - Medical Oncology London United Kingdom EC1A 7BE
    113 King's College Hospital - Haematology Clinical Trials London United Kingdom SE5 9RS
    114 Freeman Hospital - Northern Centre for Cancer Care Newcastle Upon Tyne United Kingdom NE7 7DN
    115 Nottingham City Hospital - Centre for Clinical Haematology Nottingham United Kingdom NG5 1PB
    116 Derriford Hospital - Haematology Plymouth United Kingdom PL6 8DH
    117 Royal hallamshire Hospital - Haematology Sheffield United Kingdom S10 2JF
    118 Royal Marsden NHS Foundation Trust - Haematology Surrey United Kingdom SM2 5PT
    119 Royal Wolverhampton hospitals trust - Research and development Wolverhampton United Kingdom WV10 OQP

    Sponsors and Collaborators

    • Celgene Corporation

    Investigators

    • Study Director: Robert Knight, MD, Celgene Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene Corporation
    ClinicalTrials.gov Identifier:
    NCT00064974
    Other Study ID Numbers:
    • CC-5013-MDS-002
    • NCT00077506
    First Posted:
    Jul 17, 2003
    Last Update Posted:
    Apr 4, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Celgene Corporation
    MDS
    CC-5013
    Revlimid
    Celgene
    Additional relevant MeSH terms:
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome
    Lenalidomide

    Study Results

    No Results Posted as of Apr 4, 2013