Myeloma-Developing Regimens Using Genomics (MyDRUG)

Exclusion Criteria

• •Patients will be ineligible for this study if they meet any one of the following criteria:
• •Aggressive multiple myeloma requiring immediate treatment as defined by:
• •* Lactate dehydrogenase (LDH) \> 2 times ULN
• •* Presence of symptomatic extramedullary disease or central nervous system involvement
• •* Hypercalcemia \>11.5 mg/dl
• •* Acute worsening of renal function (CrCl \< 30 ml/min) directly related to myeloma relapse
• •* Any neurological emergency related to myeloma
• •* Clinical symptoms of hyperviscosity related to monoclonal protein
• •* Involved serum free light chain \> 100 mg/dL (1000 mg/L) in the setting of prior diagnosis of cast nephropathy
• •Infection requiring systemic antibiotic therapy or other serious infection within 14 days of enrolment
• •Known hypersensitivity or development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide, pomalidomide or similar drug. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of the agents
• •Prior Ixazomib/Pomalidomide/Dexamethasone combination therapy
• •Pregnant or breast-feeding females
• •Serious medical or psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance, interfere in the completion of treatment per protocol, or follow-up evaluation
• •Active hepatitis A, B or C viral infection or known human immunodeficiency virus (HIV) infection
• •Concurrent symptomatic amyloidosis or plasma cell leukemia
• •POEMS syndrome \[plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes\]
• •Residual side effects to previous therapy \> Grade 1 prior to initiation of therapy (Alopecia any grade and/or neuropathy Grade 2 without pain are permitted)
• •Prior allogeneic or ASCT within 12 weeks of initiation of therapy. Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD)
• •Prior experimental therapy within 14 days of protocol treatment or 5 half-lives of the investigational drug, whichever is longer
• •Prior anticancer therapy within 14 days of initiation of protocol therapy (Dexamethasone/ 40mg/day) for a maximum of 4 days before screening is allowed
• •Prior major surgical procedure or radiation therapy within 4 weeks of the initiation of therapy (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of therapy).
• •Known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or Gastro Intestinal (GI) absorption of drugs administered orally
• •Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
• •Other co-morbidity, which would interfere with patient's ability to participate in trial or that confounds the ability to interpret data from the study