TriangleNCT05121103 · OUTCOME
Part 2: Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Tumour assessments were planned to be performed at Screening (within 28 days before start of study treatment) or Cycle 1 Day 1 (pre-dose) up to end of the study, approximately 23 months
What was measured
ORR was planned to be assessed in Part 2. ORR was defined as percentage of responders as assessed by Investigator per International Myeloma Working Group (IMWG) 2016 guidelines for MM (complete response \[CR\], stringent CR \[sCR\], partial response \[PR\], very good PR \[VGPR\]) or Lugano 2014 guidelines for DLBCL (CR+PR). Per IMWG response criteria, CR: negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas; \<5% plasma cells in bone marrow(BM); sCR: CR + normal free light chain (FLC) ratio; absence of BM clonal cells by immunohistochemistry; VGPR: serum and urine M-protein (MP) detected by immunofixation but not on electrophoresis or ≥90% reduction in serum MP + urine MP\<100 mg/24 hours (h) or ≥90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in soft tissue plasmacytoma; PR: ≥50% reduction of serum MP and reduction in 24 h urinary M-protein by ≥90% or to \<200 mg/24 h; ≥50% reduction in size (SPD) of soft tissue plasmacytomas.
Analysis population: The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
Groups in this outcome
Part 2: Cohort 1: R/R MM With t(4;14)
Participants with R/R MM with t(4;14) were planned to receive EZM0414 tablet at maximum tolerated dose (MTD) orally QD in continuous 28-day cycles until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
Part 2: Cohort 2: R/R MM Without t(4;14)
Participants with R/R MM without t(4;14) were planned to receive EZM0414 tablet at MTD orally QD in continuous 28-day cycles until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
Part 2: Cohort 3: R/R DLBCL
Participants with R/R DLBCL were planned to receive EZM0414 tablet at MTD orally QD in continuous 28-day cycles until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
| Group | Source count |
|---|---|
| Part 2: Cohort 1: R/R MM With t(4;14) | 0 |
| Part 2: Cohort 2: R/R MM Without t(4;14) | 0 |
| Part 2: Cohort 3: R/R DLBCL | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- ORR was planned to be assessed in Part 2. ORR was defined as percentage of responders as assessed by Investigator per International Myeloma Working Group (IMWG) 2016 guidelines for MM (complete response \[CR\], stringent CR \[sCR\], partial response \[PR\], very good PR \[VGPR\]) or Lugano 2014 guidelines for DLBCL (CR+PR). Per IMWG response criteria, CR: negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas; \<5% plasma cells in bone marrow(BM); sCR: CR + normal free light chain (FLC) ratio; absence of BM clonal cells by immunohistochemistry; VGPR: serum and urine M-protein (MP) detected by immunofixation but not on electrophoresis or ≥90% reduction in serum MP + urine MP\<100 mg/24 hours (h) or ≥90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in soft tissue plasmacytoma; PR: ≥50% reduction of serum MP and reduction in 24 h urinary M-protein by ≥90% or to \<200 mg/24 h; ≥50% reduction in size (SPD) of soft tissue plasmacytomas.
- groups
- description
- Participants with R/R MM with t(4;14) were planned to receive EZM0414 tablet at maximum tolerated dose (MTD) orally QD in continuous 28-day cycles until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
- id
- OG000
- title
- Part 2: Cohort 1: R/R MM With t(4;14)
- description
- Participants with R/R MM without t(4;14) were planned to receive EZM0414 tablet at MTD orally QD in continuous 28-day cycles until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
- id
- OG001
- title
- Part 2: Cohort 2: R/R MM Without t(4;14)
- description
- Participants with R/R DLBCL were planned to receive EZM0414 tablet at MTD orally QD in continuous 28-day cycles until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
- id
- OG002
- title
- Part 2: Cohort 3: R/R DLBCL
- population Description
- The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
- reporting Status
- POSTED
- time Frame
- Tumour assessments were planned to be performed at Screening (within 28 days before start of study treatment) or Cycle 1 Day 1 (pre-dose) up to end of the study, approximately 23 months
- title
- Part 2: Objective Response Rate (ORR)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice