Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

Exclusion Criteria

• •1. Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
• •2. Active infection or any medical condition likely to interfere with trial procedures.
• •3. Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
• •4. A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval \>500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
• •5. Patients with renal insufficiency defined as a calculated creatinine clearance of \< 45 ml/min.
• •6. Clinically significant central nervous system disorders requiring neuroleptics or anti-convulsant medication.
• •7. Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
• •8. Other malignant diseases requiring treatment
• •9. Non-secretory multiple myeloma or symptomatic amyloidosis
• •10. Pregnant or breast-feeding women
• •11. Women of childbearing age and potential, who do not use effective contraception
• •12. Known HIV positivity