TriangleNCT03194867 · OUTCOME
Phase 2: Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
What was measured
DOR: Time from date of first response (\>=PR) that was subsequently confirmed to date of first documented progressive disease (PD) or death.DOR was determined only for participants who achieved a response of PR or better.If progression or death not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiating further anticancer treatment and analysis cut-off date.PD(IMWG criteria):increase of \>=25% from lowest confirmed value in any 1 of following:serum M-protein (absolute increase\>=0.5 gram/deciliter\[g/dL\]), serum M-protein increase\>=1g/dL if lowest M component \>=5g/dL; urine M-component (absolute increase \>=200mg/24h),appearance of new lesion(s),\>=50% increase from nadir in SPD of \>1 lesion or \>=50% increase in longest diameter of a previous lesion \>1cm in short axis,\>=50% increase in circulating plasma cells (minimum 200 cells/microliter\[c/mcL\]) if that was the only measure of disease. PR: as defined in OM3.
Analysis population: The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. Only responders were included in the analysis.
Groups in this outcome
Phase 2: Isatuximab
Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
Phase 2: Isatuximab + CemiplimabQ2W
Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
Phase 2: Isatuximab + CemiplimabQ4W
Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
| Group | Source count |
|---|---|
| Phase 2: Isatuximab | 4 |
| Phase 2: Isatuximab + CemiplimabQ2W | 9 |
| Phase 2: Isatuximab + CemiplimabQ4W | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Isatuximab | 5.6 | Not reported | 4 | 7 | Not reported |
| Phase 2: Isatuximab + CemiplimabQ2W | 4.7 | Not reported | 3 | 12 | Not reported |
| Phase 2: Isatuximab + CemiplimabQ4W | 5.7 | Not reported | 2 | 12 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4
- upper Limit
- 7
- value
- 5.6
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 12
- value
- 4.7
- group Id
- OG002
- lower Limit
- 2
- upper Limit
- 12
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 8
- units
- Participants
- description
- DOR: Time from date of first response (\>=PR) that was subsequently confirmed to date of first documented progressive disease (PD) or death.DOR was determined only for participants who achieved a response of PR or better.If progression or death not observed, participant was censored at date of last valid disease assessment not showing disease progression performed prior to initiating further anticancer treatment and analysis cut-off date.PD(IMWG criteria):increase of \>=25% from lowest confirmed value in any 1 of following:serum M-protein (absolute increase\>=0.5 gram/deciliter\[g/dL\]), serum M-protein increase\>=1g/dL if lowest M component \>=5g/dL; urine M-component (absolute increase \>=200mg/24h),appearance of new lesion(s),\>=50% increase from nadir in SPD of \>1 lesion or \>=50% increase in longest diameter of a previous lesion \>1cm in short axis,\>=50% increase in circulating plasma cells (minimum 200 cells/microliter\[c/mcL\]) if that was the only measure of disease. PR: as defined in OM3.
- dispersion Type
- Full Range
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
- id
- OG000
- title
- Phase 2: Isatuximab
- description
- Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
- id
- OG001
- title
- Phase 2: Isatuximab + CemiplimabQ2W
- description
- Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
- id
- OG002
- title
- Phase 2: Isatuximab + CemiplimabQ4W
- param Type
- MEDIAN
- population Description
- The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized. Only responders were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
- title
- Phase 2: Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice