TriangleNCT03944057 · OUTCOME
Overall Response Rate (ORR)
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
- 12 months
What was measured
The primary efficacy endpoint of ORR consists of proportion of patients who achieve PR, VGPR, CR, or sCR according to IMWG 2016 criteria: * CR means Negative IFE of serum and urine, disappearance of any soft tissue plasmacytomas (SPD), and \<5% plasma cells in bone marrow aspirates; * sCR means CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells); * VGPR means Serum and urine M-protein detectable by IFE but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; * PR means ≥50% reduction of serum M-protein plus reduction in 24-hour urine M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.
Groups in this outcome
ATG-010 + Dexamethasone
Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: ATG-010 (Selinexor) will be given at an oral fixed milligram (mg) dose of 80 mg twice weekly each week for four-week cycles (total of 8 ATG-010 doses per cycle). Dexamethasone 20 mg will be given with each dose of ATG-010 (Selinexor)
| Group | Source count |
|---|---|
| ATG-010 + Dexamethasone | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ATG-010 + Dexamethasone | 24 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- The primary efficacy endpoint of ORR consists of proportion of patients who achieve PR, VGPR, CR, or sCR according to IMWG 2016 criteria: * CR means Negative IFE of serum and urine, disappearance of any soft tissue plasmacytomas (SPD), and \<5% plasma cells in bone marrow aspirates; * sCR means CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤ 4:1 or ≥ 1:2 for κ and λ patients, respectively, after counting ≥ 100 plasma cells); * VGPR means Serum and urine M-protein detectable by IFE but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; * PR means ≥50% reduction of serum M-protein plus reduction in 24-hour urine M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.
- groups
- description
- Open-label ATG-010 80mg plus Dexamethasone 20 mg ATG-010: ATG-010 (Selinexor) will be given at an oral fixed milligram (mg) dose of 80 mg twice weekly each week for four-week cycles (total of 8 ATG-010 doses per cycle). Dexamethasone 20 mg will be given with each dose of ATG-010 (Selinexor)
- id
- OG000
- title
- ATG-010 + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 12 months
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice