Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma

Exclusion Criteria

• •Peripheral neuropathy that is greater or equal to Grade 2.
• •Major surgery or, serious infections, or infections that required systemic antibiotic therapy within 14 days before the first dose of study drug.
• •Life-threatening illness unrelated to cancer.
• •Diarrhea that is greater than Grade 1 as outlined in the protocol
• •Systemic antineoplastic or radiation therapy within 14 days or cytotoxic agents, or treatment with any investigational products within 21 days before the first dose of study treatment.
• •Treatment with any investigational proteasome inhibitor.
• •Systemic treatment with prohibited medications that are outlined in the protocol within 14 days of study treatment.
• •Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day.
• •Central nervous system involvement.
• •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
• •Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
• •Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
• •Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of IXAZOMIB including difficulty swallowing.