{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants who achieved a partial response (PR) better during the study. PR is defined as \\>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \\>= 90% or to \\< 200 milligram per (mg/) 24 hours. If serum and urine M protein are not measurable, \\>= 50% decrease in difference between involved and uninvolved free light chain (FLC) levels is required in place of M protein criteria.","groups":[{"description":"Mezagitamab, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. TAK-079 dose for this phase was to be determined based on review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data obtained from the Phase 1 portion of the study. However, Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.","id":"OG000","title":"Phase 2a: Mezagitamab"}],"populationDescription":"Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.","reportingStatus":"POSTED","timeFrame":"Up to approximately 3.7 years","title":"Phase 2a: Overall Response Rate (ORR)","type":"PRIMARY"}