Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients

Inclusion Criteria

• •\-
• •1. Male or female patients 18 years or older.
• •2. Patients must be receiving a frontline bortezomib- and lenalidomide-containing regimen for treatment of disease
• •3. Patients must meet the following clinical laboratory criteria:
• •* Absolute neutrophil count (ANC) grater or equal 1,000/mm3 and platelet count greater or equal 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days prior to screening platelets or at investigator's discretion.
• •* Hemoglobin ≥ 8.0 g/dL. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed; however, most recent RBC transfusion must have been at least 7 days prior to obtaining screening hemoglobin or at investigator's discretion.
• •* Total bilirubin less or equal 1.5 times the upper limit of the normal range (ULN).
• •* Calculated or measured creatinine clearance greater or equal 30 mL/min. Calculation is based on a standard Cockcroft and Gault formula (Section 14.2).
• •* AST (SGOT) and ALT (SGPT) less or equal 3 x ULN or less or equal 5 x ULN if hepatic metastases are present.
• •* LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Mitigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
• •4. Patients must be transplant ineligible as determined by the treating physician.
• •5. Patients must have a life-expectancy of more than 6 months.
• •6. Patients must have a confirmed diagnosis of MM.
• •7. Patients receiving front-line therapy must have achieved at least PR and have completed at least 6 cycles of treatment.
• •8. The disease must have reached a plateau phase at the end of front-line treatment as demonstrated bythe same response (using IMWG criteria) in three consecutive tests with at least three weeks between each test.
• •9. Patients must have received frontline treatment within 8 weeks of enrollment.
• •10. Patient can adhere to the study visit schedule and other protocol requirements.
• •11. Patient Eastern Cooperative Oncology Group (ECOG) performance status is ≤ 2.
• •12. Patients must voluntarily give written consent before any study related procedure not part of standard medical care is performed, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• •13. Female patients must be postmenopausal for at least 1 year before screening visit OR surgically sterile. If patient is female of childbeating potential (FCBP), patient must agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug. FCBP must also adhere to the guidelines of any treatment-specific pregnancy prevention program AND agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• •14. Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
• •* To practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug
• •* To practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.