A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

Exclusion Criteria

• •Primary amyloidosis.
• •Peripheral neuropathy ≥ Grade 2 or neuropathy with pain, regardless of grade.
• •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.
• •Treatment with an investigational medicinal product or device within 28 days 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).
• •Major surgery within 14 days and minor surgery within 7 days prior to first dose of study drug.
• •Corticosteroid doses \> 10 mg/day of prednisone or equivalent within 14 days 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.