A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug.

ORR- % of participants who achieve partial response (PR) or better per IMWG criteria during study treatment. PR: >=50% reduction of serum M-protein, >=90% reduction in 24 hour urinary M-protein or to<200mg/24hour; if serum and urine M-protein are not measurable, >=50% decrease in difference between involved and uninvolved free light chain (FLC) level; if serum and urine M-protein and serum free light assay is not measurable, >=50% reduction in bone marrow plasma cell (PC), with baseline bone marrow PC% >=30%; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas; VGPR: serum and urine M-component detectable by immunofixation or >=90% reduction in serum M-protein and urine M-protein <100mg/24hour; Complete response(CR):negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

VGPR or better is defined as percentage (%) of participants with a response of very good partial response (VGPR) or better according to the International Myeloma Working Group (IMWG) criteria, during the study treatment. IMWG criteria for VGPR: serum and urine M-component detectable by immunofixation or greater than or equal to (>=)90% reduction in serum M-protein and urine M-protein less than (<)100 milligram(mg)/24hour; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; Stringent CR (sCR): CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

PFS is defined as % of participants with PFS from date of randomization to either PD, according to the IMWG criteria or death, whichever occurs first. PD: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24 hours urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24 hour; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be greater than (>)10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

Time to Response: time between the date of randomization and the first effectiveness evaluation that the participant has met all criteria for CR or PR. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5% PCs in bone marrow; PR: greater than or equal to (>=) 50% reduction of serum M-protein, >=90% reduction in 24 hour urinary M-protein or to less than (<) 200 mg/24 hours; if serum and urine M-protein are not measurable, >=50% decrease in difference between involved and uninvolved free light chains (FLC) levels; if serum and urine M-protein and serum free light assay is not measurable, >=50% reduction in bone marrow plasma cell (PC), with baseline bone marrow PC percentage >=30%; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas.

The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.

EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual.