TriangleNCT04798586 · OUTCOME
Minimal Residual Disease (MRD) Negativity Rate
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
- From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment)
What was measured
MRD negativity rate was defined as percentage of participants with CR or sCR with negative MRD per IMWG sequencing criteria by bone marrow aspirate (BMA). sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytoma and \<5% plasma cells in BMA, if disease measured by sFLC only, preceding criteria plus normal sFLC ratio. MRD was reported at threshold frequency of 10\^5 and 10\^6.
Analysis population: SAS included all enrolled participants who received at least 1 dose of study intervention.
Groups in this outcome
Elranatamab
Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
| Group | Source count |
|---|---|
| Elranatamab | 4 |
Reported measurements
Threshold: 10^5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elranatamab | 25.0 | Not reported | 0.63 | 80.59 | Not reported |
Threshold: 10^6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elranatamab | 25.0 | Not reported | 0.63 | 80.59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.63
- upper Limit
- 80.59
- value
- 25.0
- title
- Threshold: 10^5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.63
- upper Limit
- 80.59
- value
- 25.0
- title
- Threshold: 10^6
- denoms
- counts
- group Id
- OG000
- value
- 4
- units
- Participants
- description
- MRD negativity rate was defined as percentage of participants with CR or sCR with negative MRD per IMWG sequencing criteria by bone marrow aspirate (BMA). sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytoma and \<5% plasma cells in BMA, if disease measured by sFLC only, preceding criteria plus normal sFLC ratio. MRD was reported at threshold frequency of 10\^5 and 10\^6.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
- id
- OG000
- title
- Elranatamab
- param Type
- NUMBER
- population Description
- SAS included all enrolled participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment)
- title
- Minimal Residual Disease (MRD) Negativity Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice