NCT04939142 · OUTCOME
Progression-Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- month
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization until the date of first documented PD (per IMWG criteria) or date of death, whichever occurs first. Participants without PD or death at the time of analysis are censored at the date of their last adequate disease assessment.
What was measured
To evaluate progression-free survival
Groups in this outcome
SVd (Selinexor+Bortezomib+Dexamethasone)
Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles. SVd (Selinexor+Bortezomib+dexamethasone): Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
Vd (Bortezomib+Dexamethasone)
Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles. Vd (Bortezomib+dexamethasone): Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
| Group | Source count |
|---|---|
| SVd (Selinexor+Bortezomib+Dexamethasone) | 100 |
| Vd (Bortezomib+Dexamethasone) | 52 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SVd (Selinexor+Bortezomib+Dexamethasone) | 8.11 | Not reported | 6.28 | 11.99 | Not reported |
| Vd (Bortezomib+Dexamethasone) | 6.34 | Not reported | 5.55 | 11.79 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.28
- upper Limit
- 11.99
- value
- 8.11
- group Id
- OG001
- lower Limit
- 5.55
- upper Limit
- 11.79
- value
- 6.34
- denoms
- counts
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 52
- units
- Participants
- description
- To evaluate progression-free survival
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles. SVd (Selinexor+Bortezomib+dexamethasone): Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
- id
- OG000
- title
- SVd (Selinexor+Bortezomib+Dexamethasone)
- description
- Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles. Vd (Bortezomib+dexamethasone): Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
- id
- OG001
- title
- Vd (Bortezomib+Dexamethasone)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From date of randomization until the date of first documented PD (per IMWG criteria) or date of death, whichever occurs first. Participants without PD or death at the time of analysis are censored at the date of their last adequate disease assessment.
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- month
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice
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