Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma

Exclusion Criteria

• •Peripheral neuropathy that is greater or equal to Grade 2
• •Female patients who are lactating or pregnant
• •Major surgery or radiotherapy within 14 days before the first dose of study drug
• •Uncontrolled infection requiring systematic antibiotics within 14 days before the first dose of study drug
• •Diarrhea (\> Grade 1)
• •Prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
• •Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
• •Central nervous system involvement
• •Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
• •Evidence of current uncontrolled cardiovascular conditions
• •Prior or concurrent deep vein thrombosis or pulmonary embolism
• •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 allergy to any of the study medications
• •Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption, or tolerance of IXAZOMIB
• •Diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ