NCT04925193 · OUTCOME
Time to Next Treatment
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 time to next treatment 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.
Groups in this outcome
Group 1
Group 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
Group 2
Group 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
Group 3
Group 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 |
|---|---|
| Group 1 | 3 |
| Group 2 | 6 |
| Group 3 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 9.6 | Not reported | 4.5 | 13.1 | Not reported |
| Group 2 | 10.4 | Not reported | 6.7 | 16.8 | Not reported |
| Group 3 | 10.8 | Not reported | 2 | 17.17 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 13.1
- value
- 9.6
- group Id
- OG001
- lower Limit
- 6.7
- upper Limit
- 16.8
- value
- 10.4
- group Id
- OG002
- lower Limit
- 2
- upper Limit
- 17.17
- value
- 10.8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- To evaluate the time to next treatment achieved with physician's choice selinexor-based combination therapy
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Group 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
- Group 1
- description
- Group 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
- Group 2
- description
- Group 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
- Group 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.
- reporting Status
- POSTED
- time Frame
- End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
- title
- Time to Next Treatment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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