TriangleNCT03512353 · OUTCOME
Overall Response Rate (ORR) by Prior Lines of Therapy
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
- 95% Confidence Interval
- Time frame
- Disease assessments were performed every 28 days up to 12 months from enrollment.
What was measured
Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for CR confirmation), corrected calcium, and plasmacytoma evaluation, if present at screening. Best overall response is defined as a participant's best response during the study. Overall response rate is defined as the percentage of participants achieving a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
Analysis population: All enrolled and treated participants
Groups in this outcome
1 Prior Line of Therapy
Participants with 1 prior line of therapy for multiple myeloma.
2+ Prior Lines of Therapy
Participants with ≥ 2 prior lines of therapy for multiple myeloma.
| Group | Source count |
|---|---|
| 1 Prior Line of Therapy | 4 |
| 2+ Prior Lines of Therapy | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 Prior Line of Therapy | 75.0 | Not reported | 19.4 | 99.4 | Not reported |
| 2+ Prior Lines of Therapy | 100.0 | Not reported | 15.8 | 100.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.4
- upper Limit
- 99.4
- value
- 75.0
- group Id
- OG001
- lower Limit
- 15.8
- upper Limit
- 100.0
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Disease response and progression were determined using International Myeloma Working Group Uniform Response Criteria (IMWG-URC) 2016, assessed by the Investigator. Per IMWG, determination of disease response requires: serum free light chain (SFLC), serum and urine protein electrophoresis (SPEP, UPEP, respectively), serum and urine immunofixation (SIFE, UIFE, respectively), bone marrow aspirate (for CR confirmation), corrected calcium, and plasmacytoma evaluation, if present at screening. Best overall response is defined as a participant's best response during the study. Overall response rate is defined as the percentage of participants achieving a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with 1 prior line of therapy for multiple myeloma.
- id
- OG000
- title
- 1 Prior Line of Therapy
- description
- Participants with ≥ 2 prior lines of therapy for multiple myeloma.
- id
- OG001
- title
- 2+ Prior Lines of Therapy
- param Type
- NUMBER
- population Description
- All enrolled and treated participants
- reporting Status
- POSTED
- time Frame
- Disease assessments were performed every 28 days up to 12 months from enrollment.
- title
- Overall Response Rate (ORR) by Prior Lines of Therapy
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice