NCT05090566 · OUTCOME
SSB: PFS as Per IMWG Criteria as Determined by Investigator- 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
PFS=time from date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) \>=25% from lowest confirmed response value of (a)Serum M-component (absolute (abs) inc \>=0.5 g/dL) (b)Serum M-protein inc \>=1 g/dL if lowest M component \>=5 g/dL (c)Urine M-protein (abs inc \>=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc \>10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc \>=10%) (ii)appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>= 50% inc in longest diameter of a previous lesion \>1 cm in short axis (iii)\>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease.
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
- PFS=time from date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) \>=25% from lowest confirmed response value of (a)Serum M-component (absolute (abs) inc \>=0.5 g/dL) (b)Serum M-protein inc \>=1 g/dL if lowest M component \>=5 g/dL (c)Urine M-protein (abs inc \>=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc \>10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc \>=10%) (ii)appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>= 50% inc in longest diameter of a previous lesion \>1 cm in short axis (iii)\>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease.
- reporting Status
- NOT_POSTED
- time Frame
- From treatment initiation till study completion
- title
- SSB: PFS as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle