{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"26"},{"comment":"Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.","groupId":"OG002","value":"NA"},{"comment":"Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.","groupId":"OG003","value":"NA"},{"comment":"Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.","groupId":"OG004","value":"NA"}]}],"title":"Minimum value, uncensored"},{"categories":[{"measurements":[{"groupId":"OG000","value":"337"},{"groupId":"OG001","value":"169"},{"comment":"Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.","groupId":"OG002","value":"NA"},{"comment":"Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.","groupId":"OG003","value":"NA"},{"comment":"Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.","groupId":"OG004","value":"NA"}]}],"title":"Maximum value, uncensored"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"description":"Progressive disease: increase of 25% from the lowest response value in any one of the following: (a) serum M-component (absolute increase must be ≥0.5 grams per deciliter \\[g/dL\\]); (b) urine M-component (absolute increase must be ≥200 mg/24 hours); (c) only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \\> 10 mg/dL); (d) only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC) percentage (absolute percentage must be ≥10%); (d) bone marrow PC percentage: the absolute percentage must be \\> 10%; (e) definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; (f) development of hypercalcemia (corrected serum calcium \\> 11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.","groups":[{"description":"In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.","id":"OG000","title":"Phase 1: INCB001158 75 mg BID + Daratumumab"},{"description":"In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.","id":"OG001","title":"Phase 1: INCB001158 100 mg BID + Daratumumab"},{"description":"In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.","id":"OG002","title":"Phase 2: INCB001158 100 mg BID + Daratumumab"},{"description":"In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.","id":"OG003","title":"Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab"},{"description":"In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.","id":"OG004","title":"Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab"}],"paramType":"NUMBER","populationDescription":"Full Analysis Population. As a result of an early-termination decision following a recruitment challenge (no safety-related concerns), a formal analysis was not performed due to an insufficient number of participants enrolled in Phase 2. PFS was calculated for individual participants, but data were not formally analyzed.","reportingStatus":"POSTED","timeFrame":"up to approximately 2 years","title":"Progression-free Survival (PFS), Defined as the Duration From the Date of the First Dose of Study Drug Until Either Progressive Disease, as Per IMWG Criteria, or Death, Whichever Occurred First","type":"SECONDARY","unitOfMeasure":"days"}