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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

Must not have

Has discontinued bortezomib due to toxicity

History of chronic liver disease or significant unresolved liver disease; currently active (within the last 6 months) hepatic impairment according to Child-Pugh Classification B or C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 106

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I stopped taking bortezomib because of side effects.

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I do not have active severe liver disease.

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I have moderate to severe nerve pain or damage.

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I had cataract surgery more than 6 months ago and don't expect more during the study.

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I received bortezomib in my last treatment.

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My condition did not improve with initial treatment.

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My treatment has not led to significant improvement.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Change in Vital Sign Measurements

Duration of Response (DOR) for ORR

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~1410

Dexamethasone

2007