A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

Key Inclusion Criteria (Part 3):

Patients should have received at least two prior treatment regimens.
Confirmed refractory MM (measurable disease) or PCL. Patients must be refractory to treatment with both lenalidomide/dexamethasone and bortezomib/dexamethasone (or to treatment with bortezomib/lenalidomide/dexamethasone), defined as documented progressive disease on therapy or within 60 days of completing treatment with these regimens.
Previously received adequate alkylator therapy.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate hematology laboratory values without transfusion support within 2 weeks of screening.
Adequate liver and renal function.
Additional criteria exist.

Key Exclusion Criteria (Part 3):

Primary amyloidosis.
Concomitant malignancies or previous malignancies with less than a 3-year disease free interval at the time of enrollment (patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low grade prostate cancer may enroll irrespective of the time of diagnosis).
Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study drug.
Radiotherapy within 21 days prior to first dose of study drug (if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
Corticosteroid doses > 10 mg/day of prednisone or equivalent within 2 weeks prior to first dose of study drug.
Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
Additional criteria exist.