TriangleNCT04177823 · OUTCOME
Percentage of Participants With Objective Response Rate (ORR)
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
- Up to 21 months
What was measured
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]) as assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma 2016. PR=response greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 mg per 24 hours. CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. sCR=complete response below plus normal free light chain (FLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or 8-color, 2 tube multiparametric flow cytometry. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-component level \<100 mg/24 h.
Analysis population: All treated population
Groups in this outcome
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
| Group | Source count |
|---|---|
| Belantamab Mafodotin | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belantamab Mafodotin | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]) as assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma 2016. PR=response greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 mg per 24 hours. CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. sCR=complete response below plus normal free light chain (FLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or 8-color, 2 tube multiparametric flow cytometry. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-component level \<100 mg/24 h.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
- id
- OG000
- title
- Belantamab Mafodotin
- param Type
- NUMBER
- population Description
- All treated population
- reporting Status
- POSTED
- time Frame
- Up to 21 months
- title
- Percentage of Participants With Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice