NCT05090566 · OUTCOME
SSB: ORR 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
ORR: % of participants with objective response. sCR: CR \& normal sFLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas \&\<5% plasma cells in BMA. If disease measurable by sFLC only, preceding criteria \&normal sFLC ratio. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100 mg/24h; PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M-protein by \>=90% or to \<200 mg/24 hours (If disease measurable by sFLC only: VGPR \& PR: \>=90% \&\>=50% decrease in difference respectively between involved \& uninvolved sFLC levels). In addition, if present at baseline, VGPR \& PR: \>=90% \&\>=50% reduction compared with baseline in soft tissue plasmacytomas' size.
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
- ORR: % of participants with objective response. sCR: CR \& normal sFLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas \&\<5% plasma cells in BMA. If disease measurable by sFLC only, preceding criteria \&normal sFLC ratio. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100 mg/24h; PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M-protein by \>=90% or to \<200 mg/24 hours (If disease measurable by sFLC only: VGPR \& PR: \>=90% \&\>=50% decrease in difference respectively between involved \& uninvolved sFLC levels). In addition, if present at baseline, VGPR \& PR: \>=90% \&\>=50% reduction compared with baseline in soft tissue plasmacytomas' size.
- reporting Status
- NOT_POSTED
- time Frame
- From treatment initiation till study completion
- title
- SSB: ORR 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
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