TriangleNCT01953692 · OUTCOME
Objective Response Rate (ORR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to approximately 78.5 months
What was measured
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p \<100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to \<200 mg/24 hours. Cohort 2 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented.
Analysis population: All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Groups in this outcome
Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
| Group | Source count |
|---|---|
| Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) | 0.0 | Not reported | 0.0 | 9.5 | Not reported |
Source statistical analyses
- group Description
- Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- >0.9999
- p Value Comment
- one-sided p-value
- statistical Method
- exact binomial distribution
Complete source fields
- analyses
- group Description
- Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- >0.9999
- p Value Comment
- one-sided p-value
- statistical Method
- exact binomial distribution
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 9.5
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p \<100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to \<200 mg/24 hours. Cohort 2 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
- param Type
- NUMBER
- population Description
- All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Objective Response Rate (ORR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice