TriangleNCT01311687 · OUTCOME
Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria
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 randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
What was measured
Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee: CR requires all of the following: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - \<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to \< 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.
Analysis population: Intent-to-treat population
Groups in this outcome
Pomalidomide Plus Low-Dose Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
High-Dose Dexamethasone
Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
| Group | Source count |
|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 302 |
| High-Dose Dexamethasone | 153 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 22.2 | Not reported | Not reported | Not reported | Not reported |
| High-Dose Dexamethasone | 3.3 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 3.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.42
- estimate Comment
- Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- < 0.001
- param Type
- Odds Ratio (OR)
- param Value
- 8.44
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Lower Limit
- 3.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.42
- estimate Comment
- Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- < 0.001
- param Type
- Odds Ratio (OR)
- param Value
- 8.44
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 22.2
- group Id
- OG001
- value
- 3.3
- denoms
- counts
- group Id
- OG000
- value
- 302
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee: CR requires all of the following: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - \<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to \< 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.
- groups
- description
- Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
- id
- OG000
- title
- Pomalidomide Plus Low-Dose Dexamethasone
- description
- Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
- id
- OG001
- title
- High-Dose Dexamethasone
- param Type
- NUMBER
- population Description
- Intent-to-treat population
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
- title
- Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice