TriangleNCT05090566 · OUTCOME
SSB: MRD Negativity Rate as Per IMWG Criteria- Phase 1b Dose Escalation
This outcome was registered, but no numerical results were posted in the captured record.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- From treatment initiation till study completion
What was measured
MRD negativity rate is defined as the proportion of participants with CR or better by investigator and negative MRD (assessed by central lab) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurs first. 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Sequencing MRD-negative: Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as \<2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10\^5 nucleated cells.
Groups in this outcome
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- anticipated Posting Date
- 2027-03
- denom Units Selected
- Participants
- description
- MRD negativity rate is defined as the proportion of participants with CR or better by investigator and negative MRD (assessed by central lab) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurs first. 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Sequencing MRD-negative: Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as \<2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10\^5 nucleated cells.
- reporting Status
- NOT_POSTED
- time Frame
- From treatment initiation till study completion
- title
- SSB: MRD Negativity Rate as Per IMWG Criteria- Phase 1b Dose Escalation
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice