Myelodysplastic Syndrome
Conditions
Keywords
myelodysplastic syndrome
Brief summary
The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).
Interventions
DRUGCC-1088
400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related. * Age ≥ 18 at the time of signing informed consent * Patient must be able to adhere to the study visit schedule and other protocol requirements. * Patient must understand and voluntarily sign an informed consent document. * Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. * 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). * Women must not be pregnant or lactating.
Exclusion criteria
* Pregnant and lactating women and WCBP who are not using adequate contraception. * Myelosclerosis (or myelofibrosis) occupying \>30% of marrow space * Patients with iron deficiency (e.g., absent bone marrow iron store). If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be 220% and serum femtin not less than 50 ng/mL. * Patients with uncorrected Bl2 or folate deficiency. * Patients with contributing causes of anemia such as autoimmune or heredity, hemolytic disorders, or GI blood loss. * Patients with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ. * Patients with clinically significant, symptomatic and unstable pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary system diseases unrelated to their underlying hematologic disorder. * Life-threatening or active infection requiring parenteral antibiotic therapy or other serious concurrent illness. * Patients who have a history of testing positive for Hepatitis B surface antigenemia,'Hepatitis C, or HIV. * Inadequate organ hction: renal insufficiency \[serum creatinine levels \>1.5 x upper limit of normal (ULN)\] or hepatic impairment (bilirubin 22 mg/dL or AST/ALT 22 x ULN). * Patients may not have received another investigational study drug within 30 days of entry in the present study. * Requirement for ongoing therapy with corticosteroids.
Countries
United States
Outcome results
None listed