A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects With Myelodysplastic Syndromes Associated With a DEL (5q) Cytogenetic Abnormality
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of low- or intermediate-risk myelodysplastic syndromes (MDS) associated
with a del(5)(q31q33) cytogenetic abnormality
- Cytogenetic abnormality may be an isolated cytogenetic finding (the 5q-
syndrome) OR may be associated with other cytogenetic abnormalities
- Red blood cell (RBC) transfusion-dependent anemia defined as having received at least
2 units of RBCs within the past 8 weeks
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 500/mm^3
- Platelet count at least 50,000/mm^3
- No clinically significant anemia due to iron, B_12, or folate deficiency, autoimmune
or hereditary hemolysis, or gastrointestinal bleeding
- If marrow aspirate not evaluable for storage iron, the following criteria must be
met:
- Transferrin saturation at least 20%
- Serum ferritin at least 50 ng/mL
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 3.0 times upper limit of normal
Renal
- Creatinine no greater than 2.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior grade 3 or greater allergic reaction or hypersensitivity to thalidomide
- No prior grade 3 or greater rash or any desquamation (blistering) from thalidomide
- No other serious medical condition, laboratory abnormality, or psychiatric illness
that would preclude study participation or giving informed consent or confound study
results
- No other malignancy within the past 3 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix or breast
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior CC-5013
- More than 7 days since prior hematopoietic growth factors
- No concurrent epoetin alfa for MDS
Chemotherapy
- More than 28 days since prior experimental or standard chemotherapy for MDS
- No concurrent chemotherapy for MDS
Endocrine therapy
- More than 28 days since prior chronic use (greater than 2 weeks in duration) of more
than physiologic doses of corticosteroids
- No concurrent androgens for MDS
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 28 days since prior experimental or standard immunosuppressive or
cytoprotective agents for MDS
- More than 28 days since other prior experimental or standard drugs or therapy for MDS
- No other concurrent investigational agents for MDS
