TriangleNCT03361306 · OUTCOME
Number of Subjects With an Objective Response
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
- From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity. Subjects were on treatment for a median of 12 months.
What was measured
Objective response was determined for each subject as a binary variable indicating whether the subject achieved a best overall response of partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) at any time on study treatment as determined by IMWG 2016 response criteria. Per IMWG 2016 criteria, PR is defined as at least 50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by 90% or to \<200 mg/24h. VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR \>= 90% reduction in serum M protein plus urine M-protein \<100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
Analysis population: The response evaluable population is defined as all subjects who initiate treatment with elotuzumab and who have measurable disease at baseline.
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 | 12 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.519
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.957
- estimate Comment
- Confidence interval estimated using the Clopper Pearson method.
- group Ids
- OG000
- non Inferiority Comment
- Estimation only.
- non Inferiority Type
- OTHER
- param Type
- Response Rate
- param Value
- 0.800
Complete source fields
- analyses
- ci Lower Limit
- 0.519
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.957
- estimate Comment
- Confidence interval estimated using the Clopper Pearson method.
- group Ids
- OG000
- non Inferiority Comment
- Estimation only.
- non Inferiority Type
- OTHER
- param Type
- Response Rate
- param Value
- 0.800
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- Objective response was determined for each subject as a binary variable indicating whether the subject achieved a best overall response of partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) at any time on study treatment as determined by IMWG 2016 response criteria. Per IMWG 2016 criteria, PR is defined as at least 50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by 90% or to \<200 mg/24h. VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR \>= 90% reduction in serum M protein plus urine M-protein \<100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- The response evaluable population is defined as all subjects who initiate treatment with elotuzumab and who have measurable disease at baseline.
- reporting Status
- POSTED
- time Frame
- From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity. Subjects were on treatment for a median of 12 months.
- title
- Number of Subjects With an Objective Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice