{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"description":"DLT- Hematological:Grade (G)4 neutropenia \\>5 days; febrile neutropenia; G\\>=3 neutropenia, infection; G4 thrombocytopenia; G3 thrombocytopenia and G\\>=2 bleeding. Non-hematological: G\\>=4 adverse events(AEs); G3 cytokine release syndrome(CRS) \\[except CRS not been maximally treated or improved to G\\<=1 in 48 hours\\]; G3 AEs (except AEs attributed to CRS, G3 nausea, vomiting, diarrhea that improve to G2\\<=72 hours after maximal medical management has been initiated, G3 fatigue \\< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G3-4 laboratory abnormalities(except not associated with clinical sequelae and improve to G=\\<2 in 72 hours); G2 clinically important/persistent AEs(cause significant dose delay/reduction) may be DLT; G3 injection site reaction, allergic reaction, anaphylaxis. Common Terminology Criteria for Adverse Events(CTCAE) version 5.0: G1:mild AE, G2:moderate, G3:severe, G4:life-threatening consequences; urgent intervention indicated, G5:death related to AE.","groups":[{"description":"Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \\[priming dose\\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.","id":"OG000","title":"SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1"},{"description":"Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \\[priming dose\\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.","id":"OG001","title":"SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2"},{"description":"Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \\[priming dose\\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.","id":"OG002","title":"SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3"},{"description":"Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \\[priming dose\\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.","id":"OG003","title":"SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A"},{"description":"Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \\[priming dose\\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.","id":"OG004","title":"SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each investigational product (IP) were not evaluable for DLTs.","reportingStatus":"POSTED","timeFrame":"From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days)","title":"SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation","type":"PRIMARY","unitOfMeasure":"Participants"}