TriangleNCT01698801 · OUTCOME
Overall Response Rate
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
- Not reported
- Time frame
- From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
What was measured
Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder. CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Analysis population: Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.
Groups in this outcome
Lenalidomide Plus Dexamethasone
Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
| Group | Source count |
|---|---|
| Lenalidomide Plus Dexamethasone | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide Plus Dexamethasone | 87.5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 74.269
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.
- param Type
- Overall dichotomized response rate
- param Value
- 87.5
- statistical Method
- Binomial test for dichotomized response
Complete source fields
- analyses
- ci Lower Limit
- 74.269
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 100
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.
- param Type
- Overall dichotomized response rate
- param Value
- 87.5
- statistical Method
- Binomial test for dichotomized response
- classes
- categories
- measurements
- group Id
- OG000
- value
- 87.5
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- description
- Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder. CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
- groups
- description
- Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
- id
- OG000
- title
- Lenalidomide Plus Dexamethasone
- param Type
- NUMBER
- population Description
- Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
- title
- Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice