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NCT05121103 · OUTCOME

Part 2: Disease Control Rate (DCR)

A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-06-22

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

DCR was planned to be assessed in Part 2.DCR was defined as percentage of participants with confirmed CR,sCR,PR,VGPR,minimal response(MR) or stable disease(SD) per IMWG 2016 guidelines for MM/CR,PR, or SD per Lugano 2014 guidelines for DLBCL.Per IMWG response criteria,CR:negative immunofixation on serum and urine;disappearance of soft tissue plasmacytomas;\<5% plasma cells in BM; sCR:CR+normal FLC ratio;absence of BM clonal cells by immunohistochemistry; VGPR:serum and urine MP detected by immunofixation but not electrophoresis or ≥90% reduction in serum MP+urine MP\<100 mg/24h or ≥90% decrease in SPD in soft tissue plasmacytoma; PR:≥50% reduction of serum MP and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h;≥50% reduction in size(SPD) of soft tissue plasmacytomas. MR:≥25% but ≤49% reduction in serum MP and reduction in 24h urine MP by 50-89%, which exceed 200 mg/24h; ≥50% reduction in size(SPD) of soft tissue plasmacytomas.SD:Not meeting criteria for CR,VGPR,PR,MR, or PD.

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 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource 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 DLBCL0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
DCR was planned to be assessed in Part 2.DCR was defined as percentage of participants with confirmed CR,sCR,PR,VGPR,minimal response(MR) or stable disease(SD) per IMWG 2016 guidelines for MM/CR,PR, or SD per Lugano 2014 guidelines for DLBCL.Per IMWG response criteria,CR:negative immunofixation on serum and urine;disappearance of soft tissue plasmacytomas;\<5% plasma cells in BM; sCR:CR+normal FLC ratio;absence of BM clonal cells by immunohistochemistry; VGPR:serum and urine MP detected by immunofixation but not electrophoresis or ≥90% reduction in serum MP+urine MP\<100 mg/24h or ≥90% decrease in SPD in soft tissue plasmacytoma; PR:≥50% reduction of serum MP and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h;≥50% reduction in size(SPD) of soft tissue plasmacytomas. MR:≥25% but ≤49% reduction in serum MP and reduction in 24h urine MP by 50-89%, which exceed 200 mg/24h; ≥50% reduction in size(SPD) of soft tissue plasmacytomas.SD:Not meeting criteria for CR,VGPR,PR,MR, or PD.
groups
  1. description
    Participants with R/R MM with 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
    OG000
    title
    Part 2: Cohort 1: R/R MM With t(4;14)
  2. 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)
  3. 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: Disease Control Rate (DCR)
type
SECONDARY

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Preserved source evidence · Not medical advice