TriangleNCT03110562 · OUTCOME
SVd/Vd Arm: Overall Response Rate (ORR) as Assessed by IRC
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization until disease progression or initiating a new MM treatment (up to 33 months)
What was measured
ORR was defined as the percentage of the participants who achieved any confirmed partial response (PR) or better PR, complete response (CR), very good partial response (VGPR) or stringent complete response (sCR) based on the IRC's response outcome assessments, according to the International Myeloma Working Group (IMWG) response criteria, before IRC-confirmed PD or initiating a new MM treatment. PR: \>= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<= 5% plasma cells in bone marrow; or stringent complete response (sCR): CR as defined as Normal free light chain (FLC) ratio + Absence of clonal cells by immunohistochemistry.
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 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (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 twice weekly (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 | 76.4 | Not reported | 69.8 | 82.2 | Not reported |
| Vd Arm: Bortezomib + Dexamethasone | 62.3 | Not reported | 55.3 | 68.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.2641
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.0471
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0012
- p Value Comment
- One Sided P-value
- param Type
- Odds Ratio (OR)
- param Value
- 1.9626
- statistical Comment
- Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.2641
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.0471
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0012
- p Value Comment
- One Sided P-value
- param Type
- Odds Ratio (OR)
- param Value
- 1.9626
- statistical Comment
- Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 69.8
- upper Limit
- 82.2
- value
- 76.4
- group Id
- OG001
- lower Limit
- 55.3
- upper Limit
- 68.9
- value
- 62.3
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 207
- units
- Participants
- description
- ORR was defined as the percentage of the participants who achieved any confirmed partial response (PR) or better PR, complete response (CR), very good partial response (VGPR) or stringent complete response (sCR) based on the IRC's response outcome assessments, according to the International Myeloma Working Group (IMWG) response criteria, before IRC-confirmed PD or initiating a new MM treatment. PR: \>= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<= 5% plasma cells in bone marrow; or stringent complete response (sCR): CR as defined as Normal free light chain (FLC) ratio + Absence of clonal cells by immunohistochemistry.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (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 twice weekly (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
- NUMBER
- 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 disease progression or initiating a new MM treatment (up to 33 months)
- title
- SVd/Vd Arm: Overall Response Rate (ORR) as Assessed by IRC
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice