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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

RBC Transfusion Independence

Safety Issue:

No

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MDS-002

NCT ID:

NCT00064974

Start Date:

June 2003

Completion Date:

February 2007

Related Keywords:

  • Myelodysplastic Syndromes
  • MDS
  • CC-5013
  • Revlimid
  • Celgene
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Swedish Cancer InstituteSeattle, Washington  98104
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Winthrop University HospitalMineola, New York  11501
Mayo ClinicJacksonville, Florida  32224
St. Vincents Comprehensive Cancer CenterNew York, New York  10011
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Florida Cancer SpecialistsFort Myers, Florida  33901
Oregon Health & Science UniversityPortland, Oregon  97201
University of Chicago Medical CenterChicago, Illinois  60637
Indiana University Medical CenterIndianapolis, Indiana  46202
Midwest Cancer Research GroupSkokie, Illinois  60077
Mayo ClinicScottsdale, Arizona  
The Cleveland Clinic FoundationCleveland, Ohio  
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Alta Bates Cancer CenterBerkeley, California  94704
Desert Hematology Oncology Medical Group, Inc.Rancho Mirage, California  92270
Cancer & Blood Disease CenterLecanto, Florida  34461
University of Miami- Sylvester Comp Cancer CenterMiami, Florida  33136
Northwest Georgia Oncology - Wellstar Cancer ResearchMarietta, Georgia  30060
Rush Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612-3515
Wayne State University School of MedicineDetroit, Michigan  48201-2097
St. Luke's Oncology and Hematology AssociatesDuluth, Minnesota  55805
Mt. Sinai Medical CenterNew York, New York  10029
New York Hospital- CornellNew York, New York  10021-0034
University of Rochester-James P. Wilmot Cancer CenterRochester, New York  14642
Kaiser Permanente Northwest RegionPortland, Oregon  97227
Drexel University College of MedicinePhiladelphia, Pennsylvania  19129