TriangleNCT03361306 · OUTCOME
Time to Disease Progression (TTP)
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
- From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
What was measured
TTP is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death related to disease progression. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If a subject died for causes related to disease progression then progression date will be date of death. If a subject died for causes other than disease progression, TTP will be censored at the date of other cause mortality. For surviving subjects who do not have PD, TTP will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, TTP will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial TTP event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
Analysis population: The evaluable population consisted of all subjects who initiated Elo-KRd
Groups in this outcome
KRd-Elotuzumab
Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
| Group | Source count |
|---|---|
| KRd-Elotuzumab | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRd-Elotuzumab | 10.9 | Not reported | 1.9 | 17.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.1
- estimate Comment
- The Kaplan Meier method was used to estimate median TTP (in months). The Greenwood method was used to estimate confidence limits of median time to progression
- group Ids
- OG000
- non Inferiority Comment
- Estimation only
- non Inferiority Type
- OTHER
- param Type
- Median
- param Value
- 10.9
Complete source fields
- analyses
- ci Lower Limit
- 1.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.1
- estimate Comment
- The Kaplan Meier method was used to estimate median TTP (in months). The Greenwood method was used to estimate confidence limits of median time to progression
- group Ids
- OG000
- non Inferiority Comment
- Estimation only
- non Inferiority Type
- OTHER
- param Type
- Median
- param Value
- 10.9
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 17.1
- value
- 10.9
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- TTP is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death related to disease progression. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If a subject died for causes related to disease progression then progression date will be date of death. If a subject died for causes other than disease progression, TTP will be censored at the date of other cause mortality. For surviving subjects who do not have PD, TTP will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, TTP will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial TTP event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
- id
- OG000
- title
- KRd-Elotuzumab
- param Type
- MEDIAN
- population Description
- The evaluable population consisted of all subjects who initiated Elo-KRd
- reporting Status
- POSTED
- time Frame
- From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
- title
- Time to Disease Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice