SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma

Inclusion Criteria

• •Eligible patients will be considered for inclusion if they meet all of the following criteria. (All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment.)
• •1. Male or female patient who is at least 18 years of age.
• •2. Patient has given voluntary written informed consent before performance of any study-related procedures not part of standard (non-investigational) medical care.
• •3. Patient has been previously diagnosed with MM based on standard criteria.
• •4. Patient has received:
• •1. At least 2 prior therapies including a proteasome inhibitor (≥ 2 cycles) and lenalidomide (≥ 2 cycles), and
• •2. Has achieved at least stable disease (SD) for ≥ 1 cycle of treatment on ≥ 1 prior treatment, and
• •3. Has demonstrated disease progression subsequent to treatment, during or within 90 days following completion of the most recent therapy.
• •5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
• •6. Patient has measurable disease defined as at least 1 of the following:
• •1. Serum M protein ≥ 0.5 /dL (≥5 g/L)
• •2. Urine M protein ≥ 200 mg/24 hours
• •3. Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65)
• •1. Absolute neutrophil count (ANC) ≥ 1000 cells/μl (growth factor cannot be used within the previous 7 days).
• •2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).
• •3. Platelet count ≥ 50,000/μl (without platelet transfusion in the previous 7 days).
• •4. Total bilirubin ≤ 1.5 mg/dL.
• •5. Serum creatinine ≤ 2.0 mL/dL and creatinine clearance ≥ 40 mL/min (calculated by the Cockcroft-Gault Equation or per 24 hour urine collection).
• •6. Serum albumin ≥ 3.2 g/dL in the absence of receipt of (IV) albumin within the previous 72 hours.
• •7. Serum creatine phosphokinase (CPK) ≤ 2.5 × the ULN.
• •8. Serum calcium (corrected for albumin) level at or below the ULN range (treatment of hypercalcemia is allowed and patient may enroll if hypercalcemia returns to normal range with standard treatment).
• •8. Left ventricular ejection fraction (LVEF) ≥ institutional lower limit of normal as measured by multigated acquisition scan (MUGA) scan or 2-dimensional echocardiography (ECHO) within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
• •9. Females of childbearing potential (FCBP)\* must have a negative serum or urine pregnancy test prior to initiation of the SL-401 Run in Cycle (if required) and repeated with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting Pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, 1 highly effective method and 1 additional effective method at the same time, at least 28 days before she starts taking Pomalidomide through 30 days after the last dose of Pomalidomide and 60 days after the last dose of SL-401. FCBP must also agree to ongoing pregnancy testing during the entire duration of treatment. Men must agree to use a latex or synthetic condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 60 days after the last dose of Pomalidomide or SL-401. These same patients must not donate sperm. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. All patients enrolled into this study, must agree to be registered in and must comply with all requirements of the Pomalidomide REMS(TM) program.
• •* An FCBP is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).