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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00064974
First received: July 16, 2003
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Myelodysplastic Syndromes
Drug: CC-5013
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • RBC Transfusion Independence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ≥ 50% decrease in RBC transfusion requirement [ Designated as safety issue: No ]
  • Platelet Response [ Designated as safety issue: No ]
    Platelet Response

  • Neutrophil Response [ Designated as safety issue: No ]
    Neutrophil Response

  • Bone marrow Response [ Designated as safety issue: No ]
    Bone marrow Response

  • Duration of Response [ Designated as safety issue: No ]
    Duration of Response

  • Hemoglobin concentration [ Designated as safety issue: No ]
    Change of hemoglobin concentration from baseline

  • Number of Participants with Adverse Event [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Event


Enrollment: 215
Study Start Date: June 2003
Study Completion Date: February 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: lenalidomide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064974

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

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00064974     History of Changes
Obsolete Identifiers: NCT00077506
Other Study ID Numbers: CC-5013-MDS-002
Study First Received: July 16, 2003
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
MDS
CC-5013
Revlimid
Celgene

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014