Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients

Inclusion Criteria

• •1. Male or female, age 18 years or older
• •2. Patient has a diagnosis of multiple myeloma with documented relapsed and/or relapsed-refractory disease
• •3. Patient has measurable disease defined as any of the following:
• •1. Serum monoclonal protein ≥ 0.5 g/dL by protein electrophoresis
• •2. ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis
• •3. Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
• •4. If no monoclonal protein is detected, then ≥ 30% monoclonal bone marrow plasma cells
• •4. Patient has had at least 2 or more prior lines of therapy including lenalidomide and bortezomib and has demonstrated disease progression on or within 60 days of completion of the last therapy
• •5. Life expectancy of ≥6 months
• •6. Patient has an ECOG performance status ≤ 2 (Patients with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible)
• •7. Females of childbearing potential must have a negative serum or urine pregnancy test prior to patient registration
• •8. Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
• •9. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
• •10. The patient has, or accepts to have, an acceptable infusion device for infusion of melflufen
• •11. 12 lead ECG with QtcF interval ≤ 470 msec
• •12. The following laboratory results must be met within 21 days of patient registration:
• •* Absolute neutrophil count ≥ 1,000 cells/dL (1.0 x 109/L)
• •* Platelet count ≥ 75,000 cells/dL (75 x 109/L)
• •* Hemoglobin ≥ 8.0 g/dL
• •* Total Bilirubin ≤ 1.5 x upper limit of normal
• •* Renal function: Estimated creatinine clearance ≥ 45 ml/min or serum creatinine ≤ 2.5 mg/dL
• •* AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN