B-Cell Targeted Carfilzomib Desensitization

Exclusion Criteria

• •1. Patient has significant neuropathy (Grades 3 - 4, or Grade 2 with pain) by CTCAE criteria within 14 days before enrollment.
• •2. Myocardial infarction within 6 months prior to enrollment or has ADQI Heart Failure in ESRD Classification System Class 2NR or greater (Appendix B), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• •3. Patient has received other investigational drugs within 14 days prior to initiation of study treatment.
• •4. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• •5. Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of: 1) complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, 2) an in situ malignancy, 3) low-risk prostate cancer after curative therapy, or 4) any cancer with a cure rate ≥ 99%.
• •6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• •7. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
• •8. Patients with a hemoglobin count \<8 g/dL (80 g/L) (subjects may be receiving red blood cell \[RBC\] transfusions in accordance with institutional guidelines), absolute neutrophil count \< 1,000/mm3 or platelet count \< 75,000/mm3 within 14 days of consent.
• •9. Patients who are anti-HIV-positive, or HBsAg-positive, or anti-HCV positive with a detectable HCV viral load on testing performed within one year of consent.
• •10. Patients with current or recent severe systemic infections requiring treatment (systemic antibiotics, antivirals, or antifungals) within the 2 weeks prior to initiation of study treatment.
• •11. Receipt of a live vaccine within 4 weeks prior to initiation of study treatment.
• •12. Evidence of severe liver disease by medical history or physical exam with abnormal liver profile (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] or total bilirubin \> 1.5 times upper limit of normal \[ULN\]) on testing performed within 30 days of consent.
• •13. Female subject is pregnant or breast-feeding.
• •14. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
• •15. Patient is not yet on dialysis.