Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
1 other identifier
interventional
215
15 countries
119
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2003
Typical duration for phase_2
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 16, 2003
CompletedFirst Posted
Study publicly available on registry
July 17, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedApril 4, 2013
April 1, 2013
3.6 years
July 16, 2003
April 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
RBC Transfusion Independence
Secondary Outcomes (7)
≥ 50% decrease in RBC transfusion requirement
Platelet Response
Neutrophil Response
Bone marrow Response
Duration of Response
- +2 more secondary outcomes
Study Arms (1)
CC-5013
EXPERIMENTALCC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Interventions
CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (119)
Arizona Cancer Center
Scottsdale, Arizona, 85258, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Arizona Cancer Center
Tucson, Arizona, 85724-5024, United States
Alta Bates Cancer Center
Berkeley, California, 94704, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270, United States
Stanford University Medical Center
Stanford, California, 94305-5750, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Cancer & Blood Disease Center
Lecanto, Florida, 34461, United States
University of Miami- Sylvester Comp Cancer Center
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
Northwest Georgia Oncology - Wellstar Cancer Research
Marietta, Georgia, 30060, United States
Rush Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3515, United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1470, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202-5149, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287-8963, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6084, United States
Wayne State University School of Medicine
Detroit, Michigan, 48201-2097, United States
St. Luke's Oncology and Hematology Associates
Duluth, Minnesota, 55805, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Winthrop University Hospital
Mineola, New York, 11501-3893, United States
St. Vincents Comprehensive Cancer Center
New York, New York, 10011, United States
New York Hospital- Cornell
New York, New York, 10021-0034, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
University of Rochester-James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1082, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Kaiser Permanente Northwest Region
Portland, Oregon, 97227, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19129, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4417, United States
Royal Adelaide Hospital - SA Pathology Haematology
Adelaide, South Australia, 5000, Australia
Princess Alexandra Hospital - Haematology
Brisbane, 4102, Australia
Royal Prince Alfred Hospital - Institute of Haematology
Camperdown, 2050, Australia
Peter McCallum Cancer Institute - Directorate of Cancer Medecine
East Melbourne, 3002, Australia
Frankston Hospital-peninsula Health - Oncology Day Unit
Frankston, 3199, Australia
The Alfred Hospital - malignant haematology & stem cell transplantation
Melbourne, 3004, Australia
Calvary Mater Newcastle - Haematology
Waratah, 2298, Australia
Border Medical Oncology
Wodonga, 3690, Australia
Wollongong Hospital - Haematology
Wollongong, 2500, Australia
UZ Gent - Hematology
Ghent, 9000, Belgium
University Hospital Leuven - Hematology
Leuven, 3000, Belgium
Cliniques Universitaires ULC de Mont-Godinne - Hematology
Yvoir, 5530, Belgium
Fakultní nemocnice Hradec Králové - Hematology
Hradec Králové, 50005, Czechia
Charles university Hospital - Internal Medicine
Prague, 12808, Czechia
Aalborg Sygemus - Haematology
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Odense University Hospital
Odense, 5000, Denmark
Vejle Hospital - Hematology
Vejle, 7100, Denmark
CHU Angers - Service des maladies du sang
Angers, 49033, France
Centre Hospitalier de la côte basque - Hematologie
Bayonne, 64019, France
Centre Hospitalier Départemental Vendée - Onco-hematologie
La Roche-sur-Yon, 85925, France
CHRU de Lille - Service des maladies du sang
Lille, cedex 59037, France
Institut Paoli Calmette - Hematology 1
Marseille, cedex 13009, France
CHU Hôtel-Dieu - Hematologie
Nantes, cedex 01 44093, France
Hôpital Saint Louis - Immuno-hematologie
Paris, 75010, France
CHU Saint Antoine - Service des maladies du sang
Paris, cedex 12 75012, France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
Pessac, 33604, France
Centre Hospitalier Lyon sud - Hematologie
Pierre-Bénite, cedex 69495, France
CHRU Hôpital Purpan - Hematologie
Toulouse, cedex 9 31059, France
Hôpital Bretonneau - Hématologie & Thérapie cellulaire
Tours, cedex 37044, France
CHU Nancy - Hematologie
Vandœuvre-lès-Nancy, 54511, France
Universitätsklinikum Essen, Klinik für Hämatologie
Essen, 45122, Germany
Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V
Heidelberg, 69120, Germany
Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie
Jena, 7740, Germany
Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II
Leipzig, 4103, Germany
Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A
Münster, 48149, Germany
Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II
Tübingen, 72076, Germany
Universitätsklinikum Ulm - Klinik fur Innere Medizin III
Ulm, 89081, Germany
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
Würzburg, 97080, Germany
University of Athens - Alexandra Hospital; Clinical Therapeutics
Athens, 14572, Greece
Università degli Studi di Bologna - Policlinico S. Orsola - Hematology
Bologna, 40138, Italy
AO Universitaria San Martino - hematooncology
Genova, 16132, Italy
Fondazione "G. Pascale" - Hematology
Napoli, 80131, Italy
Ospedale San Luigi AO Luigi Gonzaga - Hematology
Orbassano, 10043, Italy
Universita degli Studi di Padova - Clinical & Experimental Medicine
Padua, 35128, Italy
Ospedale Guglielmo da Saliceto - hematooncology
Piacenza, 29100, Italy
Unità di Ematologia Arcispedale S. Maria Nuova - Haematology
Reggio Emilia, 42100, Italy
Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology
Roma, 00161, Italy
A.O.U. San Giovanni Battista - Hematology
Torino, 10126, Italy
VUMC - Hematology
Amsterdam, 1081 HV, Netherlands
Erasmus Medical Center - Hematology
Rotterdam, 3015 CE, Netherlands
University Medical Center - Hematology
Utrecht, 3584-CX, Netherlands
Medical Sciences - Hematology & BMT
Moscow, 125167, Russia
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology
Moscow, 125284, Russia
Russian Research Institute of Hematology and Blood Transfusion - Hematology
Saint Petersburg, 191024, Russia
State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology
Saint Petersburg, 197341, Russia
Hospital Germans Trias i Pujol - Hematology
Badalona, 8916, Spain
Hospital Clinic i Provincial de Barcelona - Hematology
Barcelona, 08036, Spain
Hospital de Donostia - Hematology
Guipúzcoa, 20014, Spain
Hospital de La Princesa - Hematology
Madrid, 28006, Spain
Hospital 12 de Octubre - Hematology
Madrid, 28041, Spain
Hospital de Salamanca - Hematology
Salamanca, 37007, Spain
Hospital Universitario Marqués de Valdecilla - Hematology
Santander, 39008, Spain
Hospital La Fe - Hematology
Valencia, 46009, Spain
Sahlgrenska Hospital, University of Goteborg - Hematology
Gothenburg, S-41345, Sweden
Karolinska University Hospital Huddinge - Center of hematology
Stockholm, 14152, Sweden
Karolinska University Hospital Solna- medicine
Stockholm, 17176, Sweden
Overlakare Medocomcentrum - Hematology
Uppsala, 75185, Sweden
Inselspital, Institut für Medizinische Onkologie
Bern, 3010, Switzerland
Hôpitaux Universitaire de Genève - Oncologie
Geneva, 1211, Switzerland
Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich
Zurich, 8091, Switzerland
Royal Bournemouth Hospital - Haematology
Bournemouth, BH7 7DW, United Kingdom
St James's University Hospital - Haematology
Leeds, LS9 7TF, United Kingdom
St Bartholomew's Hospital - Medical Oncology
London, EC1A 7BE, United Kingdom
King's College Hospital - Haematology Clinical Trials
London, SE5 9RS, United Kingdom
Freeman Hospital - Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham City Hospital - Centre for Clinical Haematology
Nottingham, NG5 1PB, United Kingdom
Derriford Hospital - Haematology
Plymouth, PL6 8DH, United Kingdom
Royal hallamshire Hospital - Haematology
Sheffield, S10 2JF, United Kingdom
Royal Marsden NHS Foundation Trust - Haematology
Surrey, SM2 5PT, United Kingdom
Royal Wolverhampton hospitals trust - Research and development
Wolverhampton, WV10 OQP, United Kingdom
Related Publications (1)
Raza A, Reeves JA, Feldman EJ, Dewald GW, Bennett JM, Deeg HJ, Dreisbach L, Schiffer CA, Stone RM, Greenberg PL, Curtin PT, Klimek VM, Shammo JM, Thomas D, Knight RD, Schmidt M, Wride K, Zeldis JB, List AF. Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1 risk myelodysplastic syndromes with karyotypes other than deletion 5q. Blood. 2008 Jan 1;111(1):86-93. doi: 10.1182/blood-2007-01-068833. Epub 2007 Sep 24.
PMID: 17893227DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Knight, MD
Celgene Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2003
First Posted
July 17, 2003
Study Start
June 1, 2003
Primary Completion
January 1, 2007
Study Completion
February 1, 2007
Last Updated
April 4, 2013
Record last verified: 2013-04