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

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 II

Drug Information available for:

Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

To evaluate the efficacy of lenalidomide [ Time Frame: Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	136
Study Start Date:	June 2003
Estimated Study Completion Date:	February 2006
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CC-5013 lenalidomide 5-mg capsules for oral administration

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 or older 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 greater than or equal 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 CC-5013.
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 SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
Lab Abnormality: Serum total bilirubin >2.0 mg/dL (34 mmol/L)
Prior greater than or equal to grade 3 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Appendix VI) allergic reaction/hypersensitivity to thalidomide.
Prior greater than or equal to 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

Show 38 Study Locations

Sponsors and Collaborators

Celgene Corporation

More Information

Publications indexed to this study:

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. Epub 2007 Sep 24.

Responsible Party:	Celgene Corporation ( Deborah Ingenito )
Study ID Numbers:	CC-5013-MDS-002
First Received:	July 16, 2003
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00064974
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

MDS

CC-5013

Revlimid

Celgene

Study placed in the following topic categories:

Myelodysplastic syndromes

Preleukemia

Precancerous Conditions

Hematologic Diseases

Myelodysplasia

Myelodysplastic Syndromes

Lenalidomide

Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Antineoplastic Agents

Therapeutic Uses

Syndrome

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00064974