{"groups":[{"description":"Mezagitamab 45 mg, subcutaneously (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 progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons.","id":"FG000","title":"Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg"},{"description":"Mezagitamab 135 mg, 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.","id":"FG001","title":"Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg"},{"description":"Mezagitamab 300 mg, 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.","id":"FG002","title":"Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg"},{"description":"Mezagitamab 600 mg, 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.","id":"FG003","title":"Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg"},{"description":"Mezagitamab 1200 mg, 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.","id":"FG004","title":"Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg"},{"description":"Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.","id":"FG005","title":"Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex"},{"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":"FG006","title":"Phase 2a: Mezagitamab"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"22"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"22"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants with a diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) were enrolled in Phase 1 to receive mezagitamab in a dose escalating manner and in combination with PomDex. Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.","recruitmentDetails":"Participants took part in the study at 7 investigative sites in the United States from 20 April 2018 to 28 January 2022."}