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NCT05121103 · OUTCOME

Part 2: Progression-free Survival (PFS)

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

PFS was planned to be assessed in Part 2. PFS was defined as the time from start of treatment until the first documented progressive disease (PD), as assessed by Investigator per IMWG 2016 guidelines for MM or Lugano 2014 guidelines for DLBCL or death due to any cause, whichever occurred first. Per IMWG response criteria, PD was defined as any 1 or more of the following criteria: a) increase of ≥25% from lowest confirmed value in either serum MP, serum MP increase ≥1 gram/deciliter (g/dL) if the lowest M-component was ≥5 g/dL or urine M-component, b) appearance of new lesion(s), ≥50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1 centimeter (cm) in short axis.

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
PFS was planned to be assessed in Part 2. PFS was defined as the time from start of treatment until the first documented progressive disease (PD), as assessed by Investigator per IMWG 2016 guidelines for MM or Lugano 2014 guidelines for DLBCL or death due to any cause, whichever occurred first. Per IMWG response criteria, PD was defined as any 1 or more of the following criteria: a) increase of ≥25% from lowest confirmed value in either serum MP, serum MP increase ≥1 gram/deciliter (g/dL) if the lowest M-component was ≥5 g/dL or urine M-component, b) appearance of new lesion(s), ≥50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1 centimeter (cm) in short axis.
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: Progression-free Survival (PFS)
type
SECONDARY

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Preserved source evidence · Not medical advice