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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 Center Tucson, Arizona  85724
MD Anderson Cancer Center Houston, Texas  77030-4096
Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Stanford University Medical Center Stanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Johns Hopkins Oncology Center Baltimore, Maryland  21287
Swedish Cancer Institute Seattle, Washington  98104
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Winthrop University Hospital Mineola, New York  11501
Mayo Clinic Jacksonville, Florida  32224
St. Vincents Comprehensive Cancer Center New York, New York  10011
Western Pennsylvania Cancer Institute Pittsburgh, Pennsylvania  15224
Florida Cancer Specialists Fort Myers, Florida  33901
Oregon Health & Science University Portland, Oregon  97201
University of Chicago Medical Center Chicago, Illinois  60637
Indiana University Medical Center Indianapolis, Indiana  46202
Midwest Cancer Research Group Skokie, Illinois  60077
Mayo Clinic Scottsdale, Arizona  
The Cleveland Clinic Foundation Cleveland, Ohio  
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Alta Bates Cancer Center Berkeley, California  94704
Desert Hematology Oncology Medical Group, Inc. Rancho Mirage, California  92270
Cancer & Blood Disease Center Lecanto, Florida  34461
University of Miami- Sylvester Comp Cancer Center Miami, Florida  33136
Northwest Georgia Oncology - Wellstar Cancer Research Marietta, Georgia  30060
Rush Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612-3515
Wayne State University School of Medicine Detroit, Michigan  48201-2097
St. Luke's Oncology and Hematology Associates Duluth, Minnesota  55805
Mt. Sinai Medical Center New York, New York  10029
New York Hospital- Cornell New York, New York  10021-0034
University of Rochester-James P. Wilmot Cancer Center Rochester, New York  14642
Kaiser Permanente Northwest Region Portland, Oregon  97227
Drexel University College of Medicine Philadelphia, Pennsylvania  19129