TriangleNCT03837509 · OUTCOME
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
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- days
- Interval / dispersion
- Not reported
- Time frame
- up to approximately 2 years
What was measured
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.
Analysis population: 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.
Groups in this outcome
Phase 1: INCB001158 75 mg BID + Daratumumab
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.
Phase 1: INCB001158 100 mg BID + Daratumumab
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.
Phase 2: INCB001158 100 mg BID + Daratumumab
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.
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab
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.
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab
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.
| Group | Source count |
|---|---|
| Phase 1: INCB001158 75 mg BID + Daratumumab | 6 |
| Phase 1: INCB001158 100 mg BID + Daratumumab | 4 |
| Phase 2: INCB001158 100 mg BID + Daratumumab | 2 |
| Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab | 1 |
| Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab | 2 |
Reported measurements
Minimum value, uncensored
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: INCB001158 75 mg BID + Daratumumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: INCB001158 100 mg BID + Daratumumab | 26 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: INCB001158 100 mg BID + Daratumumab | NA | Not reported | Not reported | Not reported | Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants. |
| Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab | NA | Not reported | Not reported | Not reported | Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants. |
| Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab | NA | Not reported | Not reported | Not reported | Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants. |
Maximum value, uncensored
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: INCB001158 75 mg BID + Daratumumab | 337 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: INCB001158 100 mg BID + Daratumumab | 169 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: INCB001158 100 mg BID + Daratumumab | NA | Not reported | Not reported | Not reported | Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants. |
| Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab | NA | Not reported | Not reported | Not reported | Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants. |
| Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab | NA | Not reported | Not reported | Not reported | Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- 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.
- group Id
- 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.
- group Id
- 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.
- group Id
- OG004
- value
- NA
- title
- Minimum value, uncensored
- categories
- measurements
- group Id
- OG000
- value
- 337
- group Id
- 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.
- group Id
- 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.
- group Id
- 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.
- group Id
- OG004
- value
- NA
- title
- Maximum value, uncensored
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- 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
- param Type
- NUMBER
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- 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
- unit Of Measure
- days
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Preserved source evidence · Not medical advice