NCT04925193 · OUTCOME
Overall Response Rate
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
- End of Therapy, on average 10 months
What was measured
To evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
Groups in this outcome
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
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
* 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm 3 | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- To evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
- groups
- description
- * 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
- 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
- * 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
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- End of Therapy, on average 10 months
- title
- Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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