Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex

Inclusion Criteria

• Males and females at least 18 years of age.
• Voluntary written informed consent before performance of any study-related procedure.
• Subject must have measurable disease of MM as defined by the criteria below:
• IgG multiple myeloma: Serum M protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or
• IgA, IgD, IgE, IgM multiple myeloma: Serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
• Light chain multiple myeloma, for subjects without measurable disease in the serum or urine: Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
• Subjects must have received prior antimyeloma treatment. The prior treatment must have included both a PI- and lenalidomide-containing regimens. The subject must have had a response (ie, PR or better based on the investigator's determination of response as defined by the modified IMWG criteria) to prior therapy.
• Subjects must have documented evidence of PD based on the investigator's determination of response as defined by the modified IMWG criteria on or after the last regimen.
• Subjects who received only 1 line of prior treatment must have demonstrated PD on or within 60 days of completion of the lenalidomide containing regimen (ie, lenalidomide refractory).
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
• Willingness and ability to participate in study procedures.
• For subjects experiencing toxicities resulting from previous therapy, the toxicities must be resolved or stabilized to ≤Grade 1.
• Any of the following laboratory test results during Screening:
• Absolute neutrophil count ≥1.0 × 109/L;
• Hemoglobin level ≥7.5 g/dL (≥4.65 mmol/L); (transfusions are not permitted to reach this level);
• Platelet count ≥75 × 109/L in subjects in whom 470 msec.
• Known active hepatitis A, B, or C.
• Known HIV infection.
• Gastrointestinal disease that may significantly alter the absorption of pomalidomide.
• Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
• Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.
• Ongoing ≥ Grade 2 peripheral neuropathy.
• Subject had ≥Grade 3 rash during prior therapy.
• Subject has had major surgery within 2 weeks before randomization, or has not fully recovered from an earlier surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration. Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.
• Pregnant or nursing women.