TriangleNCT04925193 · OUTCOME
Progression Free Survival
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
- End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
What was measured
To evaluate the duration of progression free survival achieved with physician's choice selinexor-based combination therapy
Analysis population: The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. This analysis was preplanned in the study protocol. Analysis of the secondary endpoint of progression free survival will be performed on the Intent-to-treat (ITT) population, which will include all subjects who have been enrolled for the study.
Groups in this outcome
Arm 1
Arm 1: * Selinexor 60 mg PO days 1, 8, 15 * Pomalidomide 4 mg PO on days 1-21 * Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22 * 28 day treatment cycles Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). Pomalidomide: Oral Table Dexamethasone: Oral tablet or injection
Arm 2
Arm 2: Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). Daratumumab: Injection Dexamethasone: Oral tablet or injection
Arm 3
Arm 3: * Selinexor 80 mg PO days 1, 8, 15 * Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15. * Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 * 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). Carfilzomib: Injection Dexamethasone: Oral tablet or injection
| Group | Source count |
|---|---|
| Arm 1 | 3 |
| Arm 2 | 6 |
| Arm 3 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1 | 7.6 | Not reported | 2.8 | 12.4 | Not reported |
| Arm 2 | 12.7 | Not reported | 4.5 | 20.9 | Not reported |
| Arm 3 | 17.2 | Not reported | 3.2 | 31.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 12.4
- value
- 7.6
- group Id
- OG001
- lower Limit
- 4.5
- upper Limit
- 20.9
- value
- 12.7
- group Id
- OG002
- lower Limit
- 3.2
- upper Limit
- 31.2
- value
- 17.2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- To evaluate the duration of progression free survival achieved with physician's choice selinexor-based combination therapy
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Arm 1: * Selinexor 60 mg PO days 1, 8, 15 * Pomalidomide 4 mg PO on days 1-21 * Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22 * 28 day treatment cycles Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). Pomalidomide: Oral Table Dexamethasone: Oral tablet or injection
- id
- OG000
- title
- Arm 1
- description
- Arm 2: Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). Daratumumab: Injection Dexamethasone: Oral tablet or injection
- id
- OG001
- title
- Arm 2
- description
- Arm 3: * Selinexor 80 mg PO days 1, 8, 15 * Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15. * Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 * 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). Carfilzomib: Injection Dexamethasone: Oral tablet or injection
- id
- OG002
- title
- Arm 3
- param Type
- MEDIAN
- population Description
- The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. This analysis was preplanned in the study protocol. Analysis of the secondary endpoint of progression free survival will be performed on the Intent-to-treat (ITT) population, which will include all subjects who have been enrolled for the study.
- reporting Status
- POSTED
- time Frame
- End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice