TriangleNCT01324947 · OUTCOME
Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment
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 through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.
What was measured
Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and 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.
Analysis population: Intent to treat population includes all participants enrolled.
Groups in this outcome
Pomalidomide
Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
| Group | Source count |
|---|---|
| Pomalidomide | 74 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide | 20.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20.3
- denoms
- counts
- group Id
- OG000
- value
- 74
- units
- Participants
- description
- Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and 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.
- groups
- description
- Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
- id
- OG000
- title
- Pomalidomide
- param Type
- NUMBER
- population Description
- Intent to treat population includes all participants enrolled.
- reporting Status
- POSTED
- time Frame
- From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.
- title
- Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice