TriangleNCT02011113 · OUTCOME
Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants responding
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
What was measured
Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - 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: EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
Groups in this outcome
Pomalidomide Plus 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.
| Group | Source count |
|---|---|
| Pomalidomide Plus Dexamethasone | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide Plus Dexamethasone | 38.9 | Not reported | 22.964 | 54.814 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.964
- upper Limit
- 54.814
- value
- 38.9
- denoms
- counts
- group Id
- OG000
- value
- 36
- units
- Participants
- description
- Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - 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.
- dispersion Type
- 95% Confidence Interval
- 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 Dexamethasone
- param Type
- NUMBER
- population Description
- EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
- reporting Status
- POSTED
- time Frame
- From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
- title
- Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)
- type
- SECONDARY
- unit Of Measure
- percentage of participants responding
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice