Clinical Study of CWP232291 in Relapsed or Refractory Myeloma Patients

Inclusion Criteria

• •1. Able to understand and then sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment.
• •2. ≥ 18 years of age.
• •3. Confirmed measurable MM based on the following:
• •* Serum M component (≥ 0.5 g/dL), or
• •* Urine M protein ≥ 200 mg/24 hours), or
• •* Serum immunoglobulin free light chains ≥ 10 mg/dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio), or
• •* Non-secretory disease measurable with bone marrow biopsy or radiography.
• •4. Failed 2 or more prior standard MM therapies, and \>100 days post autologous bone marrow transplant prior to first dose for transplanted subjects. Prior lenalidomide is permitted.
• •5. In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be ≥ 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. Persistent clinically significant toxicities from prior chemotherapy or radiotherapy must not be greater than Grade 1.
• •6. Eastern Cooperative Oncology Group (ECOG) performance score 0-2 (Appendix 3).
• •7. Adequate bone marrow function:
• •* Absolute neutrophil count (ANC) ≥ 1000/mm3, independent of growth factor support;
• •* Platelet count ≥ 75,000/mm3;
• •* Hb ≥ 9 g/dL (independent of transfusions or erythropoiesis-stimulating agents \[ESA\]).
• •8. Adequate renal function:
• •* Serum creatinine ≤ 2.5 mg/dL;
• •* Creatinine clearance (CrCl) ≥ 60 mL/minute (Cockcroft-Gault).
• •9. Adequate hepatic function:
• •* Total bilirubin \< 2.5 x upper limit of normal (ULN); direct bilirubin \< 2 x ULN for Gilbert's syndrome;
• •* Alkaline phosphatase (AP) ≤ 2.5 x ULN, unless considered due to organ leukemic involvement;
• •* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN.
• •11\. Women of child-bearing potential (ie, women who are premenopausal or not surgically sterile):
• •Two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 4 weeks after discontinuing study drugs, and
• •Negative serum or urine pregnancy tests during screening and then within 3 days prior to Day 1. 12. Sexually active men - effective contraceptive methods in subject and partner from the time of informed consent and until ≥ 4 weeks after discontinuing study drugs. 13. Able to adhere to the study visit schedule and other protocol requirements.