A Study of NINLARO® in Chinese Adults With Multiple Myeloma

PFS:time date of first administration of ixazomib therapy to date of first documentation of progressive disease(PD)/death,lost to follow-up,whichever occurs first as per IMWG 2016 Response Criteria.PD:increase of 25 percent(%) from lowest confirmed response value in any one/more of following:Serum and Urine M-protein only in participants without measurable serum and urine M-protein levels,difference between involved/uninvolved free light chain (FLC) levels(absolute increase greater than(>)10 milligram per deciliter [mg/dL]),and without measurable involved FLC levels, bone marrow plasma-cell% irrespective of baseline status (absolute increase must be ≥10%); appearance of new lesions, ≥50% increase from nadir in SPD of >1 lesion/ ≥50% increase in the longest diameter of a previous lesion >1 centimeter in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter [mcL]) if this is the only measure of disease. It will be analyzed using Kaplan-Meier method.

Time to next treatment will be defined as the time from the date of the first administration of ixazomib therapy to first dose of new treatment given after changing the therapy.

VGPR will be assessed as per IMWG 2016 Response Criteria, and defined as: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour (h).

CR will be assessed as per IMWG 2016 Response Criteria and defined as: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. For participants who only rely on serum FLC level as measurable lesions, in addition to meeting the above CR criteria, the ratio of serum FLC should return to normal under two consecutive assessments.

sCR will be assessed as per IMWG 2016 Response Criteria, and defined as: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. For participants who only rely on serum FLC level as measurable lesions, in addition to meeting the above CR criteria, the ratio of serum FLC should return to normal under two consecutive assessments. Absence of clonal plasma cells in bone marrow biopsy by immunohistochemistry. Presence of bone clonal plasma cells is defined as κ/λ >4:1 or <1:2 ratio under two consecutive detection by immunohistochemical method (for participants with type κ and type λ respectively, and requiring a minimum of 100 plasma cells for analysis).

DOT will be defined as the time from the date of the first administration of ixazomib therapy to the date of the last administration of ixazomib therapy.

Duration of CR will be defined as time from first documented CR to the date of PD as per IMWG 2016 Response Criteria.

OS will be defined as the time from enrollment to death from any cause.

EORTC QLQ-MY20 is self-administered patient-reported outcomes (PRO) used to assess quality of life during the last 7 days. It has 20 items evaluated on 4 point rating scale ranging from: 1 (not at all), 2 (a little), 3 (quite a bit), 4 (very much). Total score ranges from 20 to 80. Higher scores represent worsening.

EORTC QLQ-C30 is self-administered PRO which contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.

TSQM-9 is self-administered PRO. It is a 9-item, validated, self-administered instrument used to assess participant's satisfaction or dissatisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

Healthcare resource utilization will include outpatient visits to the study site, overnight hospital admissions, emergency department visits, and hospice care.

RDI is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals (dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles).