|Inclusion Criteria:||1) Confirmed relapsed or refractory MM or PCL. Patients should have received at least two prior treatment regimens. Prior treatment must have included bortezomib and an immunomodulatory agent (e.g., thalidomide and/or lenalidomide), unless patients were not eligible or refused to receive these treatments. The disease should have progressed during or after the last prior treatment regimen.|
2) In the Phase 2 with dexamethasone: Pts should have received at least 2 prior treatment regimens; Pts must have refractory disease, defined as documented disease progression during or within 60 days of completing their last myeloma therapy; All pts must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib; All pts must be refractory to treatment including lenalidomide, bortezomib and dexamethasone, defined as documented progressive disease on therapy or within 60 days of completing treatment with these regimens. The required amount of dexamethasone administered in these combination regimens is defined as at least 40 mg per week on treatment weeks; Pts must have received adequate prior alkylator therapy, defined as autologous stem cell or bone marrow transplant with melphalan, or 2 cycles of either melphalan or cyclophosphamide, depending on the regimen.
3) Measurable MM disease, defined as one of the following: a) A monoclonal immunoglobulin (Ig) concentration on serum electrophoresis of >/= 0.5 g/dL for an IgG myeloma, 0.5 g/dL for an IgA myeloma, and 0.1 g/dL for an IgD myeloma; b) Measurable urinary light chain secretion by quantitative analysis of >/= 200 mg/24 hours; c) Involved serum Free Light Chain (FLC) level >/= 10 mg/dL, provided the serum FLC ratio is abnormal;
4) Male or female, >/= 18 years of age at time of signing consent.
5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
6) Adequate hematology laboratory values without transfusion support within two weeks of screening: a) Hemoglobin >/= 8 g/dL; b) Absolute Neutrophil Count (ANC) >/= 1.5 x 10^9/L; c) Platelets >/= 75 x 10^9/L. If the bone marrow contains >/= 50% plasma cells, a platelet count of >/= 5 x 10^9/L is allowed.
7) Adequate liver and renal function: a) Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) </= 2.5 x the upper limit of normal (ULN); b) Total Bilirubin < 1.5mg/dL; c) Serum creatinine </= 2.5 mg/dL or a calculated creatinine clearance of at least 50 mL/min (using the Cockcroft and Gault method).
8) If patient is female and of childbearing potential, she must have a negative serum beta human chorionic gonadotropin (Beta-HCG) test.
9) Male patients and female patients of childbearing potential must agree to use an effective method of contraception per institutional standard. Female patients of childbearing potential must use an oral contraceptive, a double-barrier method of birth control, an intrauterine device, surgically sterilized, or the subject must be post-menopausal for a minimum of 12 months. Male patients must use a barrier method (i.e. condom w/ spermicidal jelly), be surgically sterilized or have a female partner using one of the above approved birth control methods.
10) Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care.