Participant flow

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.

groups

1. description

   Participants with translocation (t)(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 milligrams (mg) tablet orally once daily (QD) in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.

   id

   FG000

   title

   Part 1: EZM0414 100 mg

2. description

   Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.

   id

   FG001

   title

   Part 1: EZM0414 200 mg

3. description

   Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.

   id

   FG002

   title

   Part 1: EZM0414 300 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         6

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The study was planned to have a screening period (28 days), treatment period (Part 1 and Part 2) and safety follow-up period (30 days). Due to early study termination, only results of the Part 1 are presented. A total of 13 participants were enrolled in Part 1 of the study. EZM0414 is also referred to as IPN60210.

recruitment Details

This first-in-human, Phase I/Ib, open-label, multi-center study was conducted in participants with relapsed/refractory (R/R) multiple myeloma (MM) and R/R diffuse large B cell lymphoma (DLBCL) at 15 investigational sites for Part 1 (dose escalation). The study was planned to be conducted in 2 parts: Part 1 and Part 2 (dose expansion). The study was terminated prior to completing Part 1 of the study. Part 2 was not started.

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Preserved source evidence · Not medical advice