TriangleNCT03110562 · OUTCOME
SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)
What was measured
PFS was defined as time from date of randomization until the first date of IRC-confirmed PD, per International Myeloma Working Group (IMWG) response criteria, or death due to any cause, whichever occurs first. PD included increase of 25% from lowest confirmed response value in 1 or more of the following criteria: a) serum M-protein with absolute increase of \>= 0.5 gram per deciliter (g/dL); b) serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; c) urine M-protein (absolute increase must be \>= 200 mg per 24 hours); d) in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than \[\>\] 10 mg/dL); e) in participants without measurable serum and urine M-protein levels and without measurable involved FLC levels: bone marrow plasma cell percentage irrespective of baseline status (absolute increase must be \>=10%).
Analysis population: ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm.
Groups in this outcome
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
Vd Arm: Bortezomib + Dexamethasone
Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
| Group | Source count |
|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 195 |
| Vd Arm: Bortezomib + Dexamethasone | 207 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SVd Arm: Selinexor + Bortezomib + Dexamethasone | 13.93 | Not reported | 11.73 | NA | Upper limit of 95% CI was not estimable due to low number of events. |
| Vd Arm: Bortezomib + Dexamethasone | 9.46 | Not reported | 8.11 | 10.78 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.5279
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.9335
- estimate Comment
- Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0075
- p Value Comment
- One Sided P-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.7020
- statistical Comment
- Stratified for prior PI therapies, number of prior of anti-MM regimens and R-ISS Stage at screening.
- statistical Method
- Stratified Log-rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.5279
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.9335
- estimate Comment
- Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0075
- p Value Comment
- One Sided P-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.7020
- statistical Comment
- Stratified for prior PI therapies, number of prior of anti-MM regimens and R-ISS Stage at screening.
- statistical Method
- Stratified Log-rank Test
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to low number of events.
- group Id
- OG000
- lower Limit
- 11.73
- upper Limit
- NA
- value
- 13.93
- group Id
- OG001
- lower Limit
- 8.11
- upper Limit
- 10.78
- value
- 9.46
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 207
- units
- Participants
- description
- PFS was defined as time from date of randomization until the first date of IRC-confirmed PD, per International Myeloma Working Group (IMWG) response criteria, or death due to any cause, whichever occurs first. PD included increase of 25% from lowest confirmed response value in 1 or more of the following criteria: a) serum M-protein with absolute increase of \>= 0.5 gram per deciliter (g/dL); b) serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; c) urine M-protein (absolute increase must be \>= 200 mg per 24 hours); d) in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than \[\>\] 10 mg/dL); e) in participants without measurable serum and urine M-protein levels and without measurable involved FLC levels: bone marrow plasma cell percentage irrespective of baseline status (absolute increase must be \>=10%).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
- id
- OG000
- title
- SVd Arm: Selinexor + Bortezomib + Dexamethasone
- description
- Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
- id
- OG001
- title
- Vd Arm: Bortezomib + Dexamethasone
- param Type
- MEDIAN
- population Description
- ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm.
- reporting Status
- POSTED
- time Frame
- From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)
- title
- SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice