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Myelodysplastic SyndromesPhase 2NCT00064974

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

A Phase 2 study testing CC-5013 in people with Myelodysplastic Syndromes, run by Celgene Corporation at 119 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
CC-5013
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
119 sitesin 15 countries
Study dates
Jun 2003to Feb 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

119 sites in 15 countries.

119 sites in 15 countries

United States38 sites

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287-8963

  • Alta Bates Cancer Center

    Berkeley, California, 94704

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115-6084

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Rush Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612-3515

  • University of Chicago Medical Center

    Chicago, Illinois, 60637-1470

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Wayne State University School of Medicine

    Detroit, Michigan, 48201-2097

  • St. Luke's Oncology and Hematology Associates

    Duluth, Minnesota, 55805

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202-5149

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Cancer & Blood Disease Center

    Lecanto, Florida, 34461

  • Northwest Georgia Oncology - Wellstar Cancer Research

    Marietta, Georgia, 30060

  • University of Miami- Sylvester Comp Cancer Center

    Miami, Florida, 33136

  • Winthrop University Hospital

    Mineola, New York, 11501-3893

  • St. Vincents Comprehensive Cancer Center

    New York, New York, 10011

  • New York Hospital- Cornell

    New York, New York, 10021-0034

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19129

  • Western Pennsylvania Cancer Institute

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • Kaiser Permanente Northwest Region

    Portland, Oregon, 97227

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92270

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester-James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Arizona Cancer Center

    Scottsdale, Arizona, 85258

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4417

  • Midwest Cancer Research Group

    Skokie, Illinois, 60077

  • Stanford University Medical Center

    Stanford, California, 94305-5750

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Arizona Cancer Center

    Tucson, Arizona, 85724-5024

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157-1082

Other trials in United States

France13 sites

  • CHU Angers - Service des maladies du sang

    Angers, 49033

  • Centre Hospitalier de la côte basque - Hematologie

    Bayonne, 64019

  • Centre Hospitalier Départemental Vendée - Onco-hematologie

    La Roche-sur-Yon, 85925

  • CHRU de Lille - Service des maladies du sang

    Lille, cedex 59037

  • Institut Paoli Calmette - Hematology 1

    Marseille, cedex 13009

  • CHU Hôtel-Dieu - Hematologie

    Nantes, cedex 01 44093

  • Hôpital Saint Louis - Immuno-hematologie

    Paris, 75010

  • CHU Saint Antoine - Service des maladies du sang

    Paris, cedex 12 75012

  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie

    Pessac, 33604

  • Centre Hospitalier Lyon sud - Hematologie

    Pierre-Bénite, cedex 69495

  • CHRU Hôpital Purpan - Hematologie

    Toulouse, cedex 9 31059

  • Hôpital Bretonneau - Hématologie & Thérapie cellulaire

    Tours, cedex 37044

  • CHU Nancy - Hematologie

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United Kingdom10 sites

  • Royal Bournemouth Hospital - Haematology

    Bournemouth, BH7 7DW

  • St James's University Hospital - Haematology

    Leeds, LS9 7TF

  • St Bartholomew's Hospital - Medical Oncology

    London, EC1A 7BE

  • King's College Hospital - Haematology Clinical Trials

    London, SE5 9RS

  • Freeman Hospital - Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN

  • Nottingham City Hospital - Centre for Clinical Haematology

    Nottingham, NG5 1PB

  • Derriford Hospital - Haematology

    Plymouth, PL6 8DH

  • Royal hallamshire Hospital - Haematology

    Sheffield, S10 2JF

  • Royal Marsden NHS Foundation Trust - Haematology

    Surrey, SM2 5PT

  • Royal Wolverhampton hospitals trust - Research and development

    Wolverhampton, WV10 OQP

Other trials in United Kingdom

Australia9 sites

  • Royal Adelaide Hospital - SA Pathology Haematology

    Adelaide, South Australia, 5000

  • Princess Alexandra Hospital - Haematology

    Brisbane, 4102

  • Royal Prince Alfred Hospital - Institute of Haematology

    Camperdown, 2050

  • Peter McCallum Cancer Institute - Directorate of Cancer Medecine

    East Melbourne, 3002

  • Frankston Hospital-peninsula Health - Oncology Day Unit

    Frankston, 3199

  • The Alfred Hospital - malignant haematology & stem cell transplantation

    Melbourne, 3004

  • Calvary Mater Newcastle - Haematology

    Waratah, 2298

  • Border Medical Oncology

    Wodonga, 3690

  • Wollongong Hospital - Haematology

    Wollongong, 2500

Other trials in Australia

Italy9 sites

  • Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

    Bologna, 40138

  • AO Universitaria San Martino - hematooncology

    Genova, 16132

  • Fondazione "G. Pascale" - Hematology

    Naples, 80131

  • Ospedale San Luigi AO Luigi Gonzaga - Hematology

    Orbassano, 10043

  • Universita degli Studi di Padova - Clinical & Experimental Medicine

    Padova, 35128

  • Ospedale Guglielmo da Saliceto - hematooncology

    Piacenza, 29100

  • Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

    Reggio Emilia, 42100

  • Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

    Roma, 00161

  • A.O.U. San Giovanni Battista - Hematology

    Torino, 10126

Other trials in Italy

Germany8 sites

  • Universitätsklinikum Essen, Klinik für Hämatologie

    Essen, 45122

  • Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

    Heidelberg, 69120

  • Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

    Jena, 7740

  • Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

    Leipzig, 4103

  • Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

    Münster, 48149

  • Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

    Tübingen, 72076

  • Universitätsklinikum Ulm - Klinik fur Innere Medizin III

    Ulm, 89081

  • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

    Würzburg, 97080

Other trials in Germany

Spain8 sites

  • Hospital Germans Trias i Pujol - Hematology

    Badalona, 8916

  • Hospital Clinic i Provincial de Barcelona - Hematology

    Barcelona, 08036

  • Hospital de Donostia - Hematology

    Guipúzcoa, 20014

  • Hospital de La Princesa - Hematology

    Madrid, 28006

  • Hospital 12 de Octubre - Hematology

    Madrid, 28041

  • Hospital de Salamanca - Hematology

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla - Hematology

    Santander, 39008

  • Hospital La Fe - Hematology

    Valencia, 46009

Other trials in Spain

Denmark4 sites

  • Aalborg Sygemus - Haematology

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8000

  • Odense University Hospital

    Odense, 5000

  • Vejle Hospital - Hematology

    Vejle, 7100

Other trials in Denmark

Russia4 sites

  • Medical Sciences - Hematology & BMT

    Moscow, 125167

  • Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

    Moscow, 125284

  • Russian Research Institute of Hematology and Blood Transfusion - Hematology

    Saint Petersburg, 191024

  • State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

    Saint Petersburg, 197341

Other trials in Russia

Sweden4 sites

  • Sahlgrenska Hospital, University of Goteborg - Hematology

    Gothenburg, S-41345

  • Karolinska University Hospital Huddinge - Center of hematology

    Stockholm, 14152

  • Karolinska University Hospital Solna- medicine

    Stockholm, 17176

  • Overlakare Medocomcentrum - Hematology

    Uppsala, 75185

Other trials in Sweden

Belgium3 sites

  • UZ Gent - Hematology

    Ghent, 9000

  • University Hospital Leuven - Hematology

    Leuven, 3000

  • Cliniques Universitaires ULC de Mont-Godinne - Hematology

    Yvoir, 5530

Other trials in Belgium

Netherlands3 sites

  • VUMC - Hematology

    Amsterdam, 1081 HV

  • Erasmus Medical Center - Hematology

    Rotterdam, 3015 CE

  • University Medical Center - Hematology

    Utrecht, 3584-CX

Other trials in Netherlands

Switzerland3 sites

  • Inselspital, Institut für Medizinische Onkologie

    Bern, 3010

  • Hôpitaux Universitaire de Genève - Oncologie

    Geneva, 1211

  • Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

Czechia2 sites

  • Fakultní nemocnice Hradec Králové - Hematology

    Hradec Králové, 50005

  • Charles university Hospital - Internal Medicine

    Prague, 12808

Other trials in Czechia

Greece1 site

  • University of Athens - Alexandra Hospital; Clinical Therapeutics

    Athens, 14572

Other trials in Greece

About this study

Official title: A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

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.

Being tested
CC-5013
Keywords
MDS, CC-5013, Revlimid, Celgene
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-5013Drug

    Also called lenalidomide

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

Study groups in NCT00064974
Study groupRoleWhat they receive
CC-5013ExperimentalCC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Receives: Drug: CC-5013

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RBC Transfusion Independence

Secondary outcomes (7)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionJan 2007
  4. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064974
Sponsor's protocol ID
CC-5013-MDS-002
Status last verified
Apr 2013
First submitted
16 Jul 2003
Last updated
4 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17893227

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-5013 in people with Myelodysplastic Syndromes, run by Celgene Corporation at 119 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, France, United Kingdom, Australia, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RBC Transfusion Independence. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.

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