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Proteasome Inhibitor

Eftozanermin Alfa + Bortezomib + Dexamethasone for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria

Relapsed or refractory MM after receiving at least 3, but no more than 6 prior lines of therapy, including an immunomodulatory agent (IMiD), proteasome inhibitor (PI), and an anti-CD38 antibody, and has documented disease progression that occurred during or after the most recent therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 106

Awards & highlights

Study Summary

This trial is being done to find out what the best dose of eftozanermin alfa is, when given with bortezomib and dexamethasone, for people with R/R MM. The study will also look at how well the treatment works and what side effects occur.

Who is the study for?

Adults with Multiple Myeloma who've had 3-6 prior treatments including specific agents, but whose cancer has returned or stopped responding to treatment. They must have measurable disease, a life expectancy of at least 12 weeks, and good heart, liver, and kidney function. Not eligible if they've had recent bortezomib therapy or certain eye surgeries, uncontrolled liver issues, high-dose steroids recently, other MM therapies too close to the trial start date or severe neuropathy.Check my eligibility

What is being tested?

The study is testing Eftozanermin alfa (ABBV-621) combined with Bortezomib and Dexamethasone in adults with relapsed/refractory Multiple Myeloma. Participants are divided into two groups: one receives varying doses to find the optimal Phase 2 dose; the other gets this determined dose for comparison. The drugs are given over several cycles involving IV infusions and oral tablets.See study design

What are the potential side effects?

Potential side effects include reactions related to infusion such as fever or chills; blood disorders like anemia; fatigue; digestive issues like nausea or diarrhea; increased risk of infections due to immune system suppression; nerve damage that could cause pain or numbness.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma according to IMWG standards.

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My multiple myeloma has returned or didn't respond after 3-6 treatments including IMiD, PI, and anti-CD38.

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My cancer can be measured by specific blood or urine tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 106

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 106

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 106 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective Response Rate (ORR) (Dose Expansion Arm)

Recommended Phase 2 Dose (RP2D) of Eftozanermin Alfa in Combination With Bortezomib and Dexamethasone (Safety Lead-In Arm)

Secondary outcome measures

Antidrug Antibody (ADA)/Neutralizing Antibody (Nab) Assay

Change in Vital Sign Measurements

Duration of Response (DOR) for ORR

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Safety Lead-inExperimental Treatment3 Interventions

Participants will receive escalating doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine recommended phase 2 dose (RP2D).

Group II: Dose ExpansionExperimental Treatment3 Interventions

Participants will receive eftozanermin alfa at RP2D determined in Safety Lead-in part in combination with bortezomib and dexamethasone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1140

Dexamethasone

2007

Completed Phase 4

~2590

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,344 Total Patients Enrolled

34 Trials studying Multiple Myeloma

5,351 Patients Enrolled for Multiple Myeloma

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

147,058 Total Patients Enrolled

14 Trials studying Multiple Myeloma

2,447 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04570631 — Phase 1

Multiple Myeloma Research Study Groups: Dose Expansion, Safety Lead-in

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04570631 — Phase 1

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570631 — Phase 1

Frequently Asked Questions

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

Has Eftozanermin alfa been evaluated in other research studies?

"Presently, there are 592 studies actively conducted for Eftozanermin alfa. Of these trials, 146 have entered the third stage of clinical development. The majority of research has been focused upon Mishawaka in Indiana; however, 19879 sites across the US are running tests with this medication."

Answered by AI

In what number of medical facilities is this trial currently being conducted?

"This clinical trial is being held at 5 different medical centres, such as Emory University /ID# 222922 in Atlanta, University of Texas Southwestern Medical Center /ID# 223811 in Dallas and Dana-Farber Cancer Institute/ ID# 222174 in Boston. Other sites are also available for recruitment."

Answered by AI

What are the aims of this exploration?

"The prime objective of this clinical trial is to evaluate the Objective Response Rate (ORR) for patients after their first dose. Secondary outcomes measure include assessment of abnormal laboratory tests, serum concentration prior to administration, and overall response rate per IMWG criteria over a period lasting up to 3 weeks."

Answered by AI

What ailments are typically alleviated by Eftozanermin alfa?

"Eftozanermin alfa is an effective treatment for ophthalmia, sympathetic and other eye-related diseases such as branch retinal vein occlusion or macular edema."

Answered by AI

What are the potential adverse effects associated with Eftozanermin alfa?

"In light of the Phase 1 trial data, our experts at Power have given Eftozanermin alfa a score of one on a three-point scale to denote its limited safety and efficacy."

Answered by AI

How many individuals are participating in the experiment?

"Sadly, this research trial is not currently seeking enrolments. The clinical study was first announced on November 5th 2020 and the last update occurred on October 12 2022. If you are looking to take part in other drug trials, 807 studies related to multiple myeloma and 592 involving Eftozanermin alfa have open slots for participants."

Answered by AI

Does this research endeavor have any available openings for participants?

"Unfortunately, recruitment for this trial has concluded. The initial post was made on November 5th 2020 and the last update occurred on October 12th 20212. Should you seek other trials to join, there are 807 studies open for multiple myeloma patients and a further 592 clinical investigations enrolling individuals who can benefit from Eftozanermin alfa treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma

2020. "Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570631.

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