TriangleNCT03275285 · OUTCOME
Number of Participants With Renal Response (RR): Primary Analysis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose of study treatment to 30 days following the last administration of study treatment (maximum duration: up to 114 weeks)
What was measured
RR comprises of complete RR (CR renal), partial RR (PR renal) \& minor RR (MR renal). CR renal was defined as an improvement in estimated glomerular filtration rate (eGFR) from \<50 mL/min/1.73m\^2 at Baseline to \>=60 mL/min/1.73m\^2 in at least 1 assessment during the treatment period (time from first dose of study treatment up to 30 days after last dose of study treatment); PR renal was defined as improvement in eGFR from \<15 mL/min/1.73m\^2 at baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m\^2 during the on-treatment-period and MR renal was defined as an improvement in eGFR from \<15 mL/min/1.73m\^2 at Baseline to at least 1 assessment in the range of 15 to 30 mL/min/1.73m\^2 during the on-treatment-period or from 15 to 30 mL/min/1.73m\^2 at Baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m\^2 during the on-treatment-period.
Analysis population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' signifies participants with available data for each specified category. Here, "0" signifies that none of the participants were available for assessment at the specified timepoint.
Groups in this outcome
Carfilzomib + Dexamethasone (Kd)
Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).
Isatuximab + Carfilzomib + Dexamethasone (IKd)
Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
| Group | Source count |
|---|---|
| Carfilzomib + Dexamethasone (Kd) | 13 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 25 |
Reported measurements
CR Renal
| Group | Source count |
|---|---|
| Carfilzomib + Dexamethasone (Kd) | 13 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 25 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 4 | Not reported | Not reported | Not reported | Not reported |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 13 | Not reported | Not reported | Not reported | Not reported |
PR Renal
| Group | Source count |
|---|---|
| Carfilzomib + Dexamethasone (Kd) | 0 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 0 |
MR Renal
| Group | Source count |
|---|---|
| Carfilzomib + Dexamethasone (Kd) | 3 |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib + Dexamethasone (Kd) | 1 | Not reported | Not reported | Not reported | Not reported |
| Isatuximab + Carfilzomib + Dexamethasone (IKd) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 25
- units
- Participants
- title
- CR Renal
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- PR Renal
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- MR Renal
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- RR comprises of complete RR (CR renal), partial RR (PR renal) \& minor RR (MR renal). CR renal was defined as an improvement in estimated glomerular filtration rate (eGFR) from \<50 mL/min/1.73m\^2 at Baseline to \>=60 mL/min/1.73m\^2 in at least 1 assessment during the treatment period (time from first dose of study treatment up to 30 days after last dose of study treatment); PR renal was defined as improvement in eGFR from \<15 mL/min/1.73m\^2 at baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m\^2 during the on-treatment-period and MR renal was defined as an improvement in eGFR from \<15 mL/min/1.73m\^2 at Baseline to at least 1 assessment in the range of 15 to 30 mL/min/1.73m\^2 during the on-treatment-period or from 15 to 30 mL/min/1.73m\^2 at Baseline to at least 1 assessment in the range of 30 to 60 mL/min/1.73m\^2 during the on-treatment-period.
- groups
- description
- Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).
- id
- OG000
- title
- Carfilzomib + Dexamethasone (Kd)
- description
- Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
- id
- OG001
- title
- Isatuximab + Carfilzomib + Dexamethasone (IKd)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' signifies participants with available data for each specified category. Here, "0" signifies that none of the participants were available for assessment at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment to 30 days following the last administration of study treatment (maximum duration: up to 114 weeks)
- title
- Number of Participants With Renal Response (RR): Primary Analysis
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice