A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant

Inclusion Criteria:

1. Adult male or female participants 18 years or older with a confirmed diagnosis ofsymptomatic multiple myeloma according to standard criteria.

2. Documented results of cytogenetics/ fluorescence in situ hybridization (FISH)obtained at any time before transplant, and International Staging System (ISS)staging at the time of diagnosis available.

3. Underwent standard of care (SOC) induction therapy (induction therapy must includeproteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens asprimary therapy for multiple myeloma), followed by a single autologous stem celltransplant (ASCT) with a high-dose melphalan (200 mg/m^2) conditioning regimen,within 12 months of diagnosis. Vincristine, Adriamycin [doxorubicin], anddexamethasone (VAD) is not an acceptable induction therapy for this trial.

4. Started screening no earlier than 75 days after transplant, completed screeningwithin 15 days, and randomized no later than 115 days after transplant.

5. Must have not received post-ASCT consolidation therapy.

6. Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR])according to IMWG criteria.

7. ECOG performance status of 0 to 2.

8. Female participants who:

• If they are of childbearing potential, agree to practice 2 effective methods ofcontraception, at the same time, from the time of signing the informed consentthrough 90 days after the last dose of study drug, AND

• Must also adhere to the guidelines of any treatment-specific pregnancyprevention program, if applicable, OR

• Agree to practice true abstinence, when this is in line with the preferred andusual lifestyle of the participant. (Periodic abstinence [eg, calendar,ovulation, symptothermal, postovulation methods for the female partner] andwithdrawal are not acceptable methods of contraception.) Male participants,even if surgically sterilized (ie, status postvasectomy), who:

• Agree to practice effective barrier contraception during the entire studytreatment period and through 90 days after the last dose of study drug, AND

• Must also adhere to the guidelines of any treatment-specific pregnancyprevention program, if applicable, OR

• Agree to practice true abstinence, when this is in line with the preferred andusual lifestyle of the participant. (Periodic abstinence [eg, calendar,ovulation, symptothermal, postovulation methods for the female partner] andwithdrawal are not acceptable methods of contraception.)

9. Voluntary written consent must be given before performance of any study-relatedprocedure not part of standard medical care, with the understanding that consent maybe withdrawn by the participant at any time without prejudice to future medicalcare.

10. Suitable venous access for the study-required blood sampling.

11. Is willing and able to adhere to the study visit schedule and other protocolrequirements.

12. Must meet the following clinical laboratory criteria at study entry:

• Absolute neutrophil count (ANC) ≥ 1,000 per cubic milliliter (/mm^3) andplatelet count ≥ 75,000/mm^3. Platelet transfusions to help participants meeteligibility criteria are not allowed within 3 days before randomization.

• Total bilirubin ≤ 1.5 * the upper limit of the normal range (ULN).

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 * ULN.

• Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min).

Exclusion Criteria:

1. Multiple myeloma that has relapsed following primary therapy or is not responsive toprimary therapy. For this study, stable disease following ASCT will be considerednonresponsive to primary therapy.

2. Double (tandem) ASCT.

3. Radiotherapy within 14 days before the first dose of study drug.

4. Diagnosed or treated for another malignancy within 5 years before randomization orpreviously diagnosed with another malignancy with evidence of residual disease.Participants with nonmelanoma skin cancer or carcinoma in situ of any type are notexcluded if they have undergone complete resection.

5. Female participants who are lactating and breastfeeding or have a positive serumpregnancy test during the Screening period.

6. Major surgery within 14 days before randomization.

7. Central nervous system involvement.

8. Infection requiring intravenous (IV) antibiotic therapy or other serious infectionwithin 14 days before randomization.

9. Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly,endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cellleukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferativesyndrome.

10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolledhypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heartfailure, unstable angina, or myocardial infarction within the past 6 months.

11. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin,rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgobiloba or St. John's wort within 14 days before randomization in the study.

12. Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV)positive.

13. Comorbid systemic illnesses or other severe concurrent disease which, in thejudgment of the investigator, would make the participant inappropriate for entryinto this study or interfere significantly with the proper assessment of safety andtoxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 withpain or Grade 2 or higher of any cause).

14. Psychiatric illness/social situation that would limit compliance with studyrequirements.

15. Known allergy to any of the study medications, their analogues, or excipients in thevarious formulations of any agent.

16. Inability to swallow oral medication, inability or unwillingness to comply with thedrug administration requirements, or gastrointestinal (GI) procedure that couldinterfere with the oral absorption or tolerance of treatment.

17. Treatment with any investigational products within 60 days before the first dose ofthe study drug regimen.