TriangleNCT02685826 · OUTCOME
Participants Who Had Either Disease Progression or Death
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
- Day 1 up to Week 84
What was measured
This outcome was originally defined as a Kaplan-Meier estimate of progression-free survival (PFS) which estimated the time between first date of dosing of study medication and disease progression, as determined by the investigator using the IMWG Uniform Response Criteria, or death during study treatment, whichever occurred earlier. However due to the early study termination and limited follow-up time, the majority of participants were censored for PFS analysis. Data reported instead represent the number of participants who died during study treatment or had disease progression within 90 days of the last dose of durvalumab.
Analysis population: Safety population
Groups in this outcome
Cohort A: High Risk, TNE
High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
Cohort B: >=65 Years Old, TNE
\>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
Cohort C: High Risk, Post-transplant
High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Cohort A: High Risk, TNE | 25 |
| Cohort B: >=65 Years Old, TNE | 10 |
| Cohort C: High Risk, Post-transplant | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: High Risk, TNE | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort B: >=65 Years Old, TNE | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort C: High Risk, Post-transplant | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 21
- units
- Participants
- description
- This outcome was originally defined as a Kaplan-Meier estimate of progression-free survival (PFS) which estimated the time between first date of dosing of study medication and disease progression, as determined by the investigator using the IMWG Uniform Response Criteria, or death during study treatment, whichever occurred earlier. However due to the early study termination and limited follow-up time, the majority of participants were censored for PFS analysis. Data reported instead represent the number of participants who died during study treatment or had disease progression within 90 days of the last dose of durvalumab.
- groups
- description
- High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG000
- title
- Cohort A: High Risk, TNE
- description
- \>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
- id
- OG001
- title
- Cohort B: >=65 Years Old, TNE
- description
- High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
- id
- OG002
- title
- Cohort C: High Risk, Post-transplant
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Day 1 up to Week 84
- title
- Participants Who Had Either Disease Progression or Death
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice