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EZM0414 for Multiple Myeloma and Lymphoma

Phase 1

Recruiting

Research Sponsored by Epizyme, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of childbearing potential must not have had unprotected sexual intercourse while participating in this study.

Females must not be breastfeeding or pregnant at screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 3 years

Awards & highlights

Study Summary

This trial is testing a new drug to treat multiple myeloma and lymphoma. The drug is taken orally, and the trial will test safety, tolerability, and effectiveness.

Who is the study for?

This trial is for adults over 18 with blood cancers that have returned or stopped responding to treatment. It's specifically for those with Multiple Myeloma (MM) or Diffuse Large B-Cell Lymphoma (DLBCL). Participants must be in fair health, not pregnant, and willing to use contraception. They can't join if they've had certain treatments, infections like COVID-19, recent major surgery, heart problems, other active cancers besides MM or DLBCL.Check my eligibility

What is being tested?

The study tests EZM0414 on patients whose blood cancer has relapsed/refractory MM or DLBCL. The first phase finds the safest dose by testing six levels every 28 days. In the second phase, participants get this safe dose regularly to see how effective it is against their cancer.See study design

What are the potential side effects?

While specific side effects of EZM0414 aren't listed here, common ones in trials may include nausea, fatigue, allergic reactions to drug components and potential impacts on heart rhythm as indicated by exclusion criteria related to QT interval prolongation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had unprotected sex during this study.

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I am not pregnant or breastfeeding.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a man and will use a condom or abstain from sex during the study and for 30 days after.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concomitant medication monitoring

Part 1 Phase 1: Dose limiting toxicities (DLT)

Part 2 Phase 1b: Establishing Maximum Tolerated Dose (MTD) and a recommended Phase 2 Dose (RP2D)

+7 more

Secondary outcome measures

Part 2 Phase 1b: Disease Control Rate (DCR)

Part 2 Phase 1b: Duration of response (DOR)

Part 2 Phase 1b: Progression-free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-label EZM0414Experimental Treatment1 Intervention

Participants will receive EZM0414 in continuous 28-day cycles. EZM0414 will be administered orally once daily (QD) without food. Participants who receive EZM0414 at Maximum tolerated dose (MTD) and do not have Dose limiting toxicities (DLT) in the dose escalation part of the study will be rolled over to a cohort of this dose expansion part. Cohort 1 for R/R MM Participants. Cohort 2 for R/R MM Participants. Cohort 3 for Participants with R/R DLBCL.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Epizyme, Inc.Lead Sponsor

33 Previous Clinical Trials

2,830 Total Patients Enrolled

Ipsen Medical DirectorStudy DirectorIpsen

257 Previous Clinical Trials

55,121 Total Patients Enrolled

Media Library

EZM0414 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05121103 — Phase 1

Multiple Myeloma Research Study Groups: Open-label EZM0414

Multiple Myeloma Clinical Trial 2023: EZM0414 Highlights & Side Effects. Trial Name: NCT05121103 — Phase 1

EZM0414 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05121103 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is EZM0414 an effective treatment with few side effects?

"EZM0414 is still in Phase 1 testing, meaning that there is limited data to support its safety and efficacy. Our team rates it as a 1."

Answered by AI

Are patients still being recruited for this clinical trial?

"That is correct, the trial detailed on clinicaltrials.gov is looking for patients right now. The listing went up on November 11th 2021 and was last edited August 10th 2022. They are recruiting for a 96 person study at 7 different locations."

Answered by AI

Please tell us how many hospitals are participating in this study.

"This study is enrolling patients from 8 clinical sites, which are: Astera Cancer Care in East Brunswick, Maryland; Rcca Md Llc in Chevy Chase, Virginia; NEXT Virginia in Fairfax, Texas; as well as 5 additional locations."

Answered by AI

Are there any enrollment limits to this clinical research?

"Epizyme, Inc. needs 96 individuals that match the clinical study's inclusion criteria to begin testing. These tests will take place in Maryland at Astera Cancer Care and Rcca Md Llc in Chevy Chase, Virginia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma

2021. "A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05121103.

All > Diffuse Large B Cell Lymphoma