Carfilzomib Thalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Inclusion Criteria

• •1. Male and female patients, ≥18 years of age
• •2. Relapsed and/or refractory multiple myeloma at study entry.
• •3. Patients must have evaluable multiple myeloma with at least one of the following (assessed within 21 days prior to registration):
• •1. Serum M-protein ≥ 5 g/L, or
• •2. Urine M-protein ≥ 200 mg/24 hour, or In patients without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal serum k/l ratio or For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 7500 mg/L (7.5 g/L).
• •4. Received one, but no more than three prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
• •5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• •6. Adequate hepatic function within 28 days prior to registration with bilirubin \< 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times the ULN.
• •7. LVEF ≥ 40%.
• •8. Absolute neutrophil count (ANC) ≥ 1000/mm3 (or 1000 cells/L) within 21 days prior to registration. Screening ANC should be independent of growth factor support for ≥ 1 week.
• •9. Platelet count ≥ 50,000 cells/mm3 (≥ 30,000 cells/mm3 if myeloma involvement in the bone marrow is \> 50%) within 21 days prior to registration. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
• •10. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to registration. Calculation should be based on the Cockcroft and Gault formula (Appendix 3)
• •11. Written informed consent in accordance with federal, local, and institutional guidelines.
• •12. Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test within 21 days prior to registration and agree to use an effective method of contraception during and for 3 months following last dose of drug.
• •13. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.
• •7. Patients with known cirrhosis.
• •8. Active malignancy, that is expected to require treatment with chemotherapy within one year, or results in a life expectancy less than one year.
• •9. Female patients who are pregnant or lactating.
• •10. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
• •11. Patients with hypersensitivity to carfilzomib, velcade, boron, or mannitol.
• •12. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to registration.
• •13. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to registration.
• •14. Any other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent.