TriangleNCT02812706 · OUTCOME
Phase 1: Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- weeks
- Interval / dispersion
- Standard Deviation
- Time frame
- From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)
What was measured
DOR: time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): increase (inc.) of \>=25% from lowest response value in any one of following: serum M-component (absolute inc.\>=0.5 g/dL) and/or; urine M-component (absolute inc.\>=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein: difference between involved \& uninvolved FLC levels (absolute inc. \>10 mg/dL); in participants without measurable serum \& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute % \>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.
Analysis population: Analysis was performed on a subset of participants who had response.
Groups in this outcome
Phase 1, Cohort 1: Isatuximab 10 mg/kg
Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
Phase 1, Cohort 2: Isatuximab 20 mg/kg
Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
| Group | Source count |
|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 2 |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1: Isatuximab 10 mg/kg | 100.64 | 7.78 | Not reported | Not reported | Not reported |
| Phase 1, Cohort 2: Isatuximab 20 mg/kg | 113.90 | 18.45 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7.78
- value
- 100.64
- group Id
- OG001
- spread
- 18.45
- value
- 113.90
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- DOR: time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): increase (inc.) of \>=25% from lowest response value in any one of following: serum M-component (absolute inc.\>=0.5 g/dL) and/or; urine M-component (absolute inc.\>=200 mg/24h) and/or, in participants without measurable serum \& urine M-protein: difference between involved \& uninvolved FLC levels (absolute inc. \>10 mg/dL); in participants without measurable serum \& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute % \>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
- id
- OG000
- title
- Phase 1, Cohort 1: Isatuximab 10 mg/kg
- description
- Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
- id
- OG001
- title
- Phase 1, Cohort 2: Isatuximab 20 mg/kg
- param Type
- MEAN
- population Description
- Analysis was performed on a subset of participants who had response.
- reporting Status
- POSTED
- time Frame
- From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)
- title
- Phase 1: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice