Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndromes (MDS)
- Requires treatment or transfusion support for MDS, as indicated by 1 of the
following:
- Demonstrates transfusion or epoetin alfa dependence
- Transfusion dependence is defined as requiring ≥ 2 units of packed RBCs
within an 8-week period prior to study entry
- Hemoglobin < 11g/dL on 2 separate occasions 2 weeks apart
- No iron, cyanocobalamin (vitamin B_12), or folic acid deficiency or other
causes of anemia
- Must have 1 of the following FAB subtypes:
- Refractory anemia
- Refractory anemia with ringed sideroblasts
- Refractory anemia with excess blasts
- Secondary MDS (if ≥ 3 years since active primary cancer)
- No chronic myelomonocytic leukemia
- Not refractory to platelet transfusion support (i.e., inability to maintain platelet
count > 20,000/mm^3 with transfusion)
- No current acute myelogenous leukemia (e.g., > 30% blasts)
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 50-100%
Life expectancy
- At least 6 months
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin ≤ 2 mg/dL
- AST and ALT < 2 times upper limit of normal
Renal
- Creatinine clearance ≥ 30 mL/min
Cardiovascular
- No significant cardiovascular condition that would preclude study participation
- No uncontrolled hypertension
Pulmonary
- No significant pulmonary condition that would preclude study participation
Immunologic
- No serious concurrent infection
- Active infections must be adequately treated with antibiotics prior to study
entry
- No hypersensitivity to bortezomib, boron, or mannitol
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 4 weeks after
completion of study treatment
- No peripheral neuropathy ≥ grade 2
- No uncontrolled seizure activity, as defined by no activity within the past year on
stable anticonvulsant medications
- No other malignancy within the past 3 years except adequately treated basal cell skin
cancer or carcinoma in situ of the cervix
- No endocrine, neurologic, or other systemic disease that would preclude study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior allogeneic bone marrow transplantation
- Concurrent transfusion support allowed
- Concurrent epoetin alfa or darbepoetin alfa allowed if initiated before start of
study therapy, dose is stable for ≥ 4 weeks, and dose is stable during study
participation
- No concurrent platelet growth factor support
- No concurrent thalidomide
Chemotherapy
- No concurrent chemotherapy
- No concurrent hydroxyurea
Endocrine therapy
- Concurrent corticosteroids for chronic autoimmune or inflammatory condition allowed
if initiated before start of study therapy and maintained on a stable or decreasing
dose
Other
- Recovered from all prior therapies
- At least 4 weeks since prior MDS therapy, except epoetin alfa, darbepoetin alfa,
filgrastim (G-CSF), pegfilgrastim (G-CSF), or transfusion support
- At least 30 days since prior investigational agents
- No prior bortezomib
- No other concurrent investigational agents
- No other concurrent therapy for MDS