A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
1. Multiple myeloma diagnosed by standard criteria.
2. Measurable levels of monoclonal protein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24
3. At least 1 prior therapies for multiple myeloma with documented evidence of
progression on the most recent treatment.
4. Age 18 years or older.
5. ECOG performance status <= 2.
6. Acceptable organ and marrow function as defined below:
- Hemoglobin >= 8 gm/dL
- Absolute neutrophil count >= 1,000/mm3
- Platelets >= 50,000/mm3
- Total bilirubin <= 2.5 X institutional upper limit of normal
- AST, ALT <= 2.5 X institutional upper limit of normal
- Creatinine 1.5 x institutional upper limit of normal
- Normal cardiac function as determined by standard institutional methods
7. Women of child bearing potential must agree to use adequate contraception prior to
study entry and for the duration of study.
8. Ability to understand and the willingness to sign a written informed consent
1. Receiving any other investigational agents.
2. Receiving concurrent steroids with a dose equivalent of prednisone of >= 150
3. Pregnant or nursing.
4. Active systemic infection considered opportunistic, life threatening or clinically
significant at the time of treatment.
5. Severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled
hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery
disease, or symptomatic CNS involvement or psychiatric illness/social situations that
would limit compliance with study requirements.
6. History of other malignancy except for basal cell or squamous cell carcinoma of the
skin or carcinoma in situ of the cervix or breast unless the subject has been off
treatment and free from disease for >= 3 years.