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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00064974
Registration number
NCT00064974
Ethics application status
Date submitted
16/07/2003
Date registered
17/07/2003
Date last updated
4/04/2013
Titles & IDs
Public title
Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
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Scientific title
A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
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Secondary ID [1]
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CC-5013-MDS-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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Other blood disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CC-5013
Experimental: CC-5013 - CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Treatment: Drugs: CC-5013
CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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RBC Transfusion Independence
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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= 50% decrease in RBC transfusion requirement
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Assessment method [1]
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Secondary outcome [2]
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Platelet Response
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Platelet Response
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Secondary outcome [3]
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Neutrophil Response
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Assessment method [3]
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Neutrophil Response
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Timepoint [3]
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Secondary outcome [4]
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Bone marrow Response
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Assessment method [4]
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Bone marrow Response
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Timepoint [4]
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Secondary outcome [5]
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Duration of Response
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Duration of Response
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Secondary outcome [6]
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Hemoglobin concentration
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Change of hemoglobin concentration from baseline
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Timepoint [6]
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Secondary outcome [7]
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Number of Participants with Adverse Event
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Assessment method [7]
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Timepoint [7]
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2007
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Sample size
Target
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Accrual to date
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Final
215
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital - SA Pathology Haematology - Adelaide
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Princess Alexandra Hospital - Haematology - Brisbane
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Royal Prince Alfred Hospital - Institute of Haematology - Camperdown
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Peter McCallum Cancer Institute - Directorate of Cancer Medecine - East Melbourne
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Frankston Hospital-peninsula Health - Oncology Day Unit - Frankston
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The Alfred Hospital - malignant haematology & stem cell transplantation - Melbourne
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Calvary Mater Newcastle - Haematology - Waratah
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Border Medical Oncology - Wodonga
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Wollongong Hospital - Haematology - Wollongong
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5000 - Adelaide
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4102 - Brisbane
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2050 - Camperdown
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3002 - East Melbourne
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3199 - Frankston
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3004 - Melbourne
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2298 - Waratah
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3690 - Wodonga
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2500 - Wollongong
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celgene Corporation
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00064974
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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Robert Knight, MD
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Address
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Celgene Corporation
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00064974
Download to PDF