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Monoclonal Antibodies

ABBV-383 for Multiple Myeloma

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance of <= 2.

Confirmed diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment based on the Investigator's determination of the international myeloma working group (IMWG) (2016) response criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to compare the effectiveness of a new drug called ABBV-383 with standard therapies in adults with relapsed or refractory multiple myeloma. Around 380 participants from different locations

Who is the study for?

This trial is for adults with multiple myeloma that has returned or hasn't improved after treatment. They must have had at least two prior therapies, including specific inhibitors and antibodies, but not BCMA-targeted therapy. Participants need to be physically able to perform daily activities with some limitations (ECOG <=2) and meet certain lab criteria.

What is being tested?

The study compares ABBV-383 given intravenously in 28-day cycles against standard available therapies chosen by the investigator. It aims to see how well ABBV-383 works compared to these treatments over a period of 3.5 years in about 380 participants worldwide.

What are the potential side effects?

Potential side effects are not specified here, but generally for cancer trials like this one can include fatigue, nausea, allergic reactions from infusions, blood count changes increasing infection risk, kidney or liver function changes.

Eligibility Criteria

Inclusion Criteria

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

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I can do most of my daily activities on my own.

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My multiple myeloma has returned or didn't respond to treatment, as confirmed by tests.

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I've had at least 2 treatments including a PI, an IMiD, and an anti-CD38 mAb.

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I have never been treated with BCMA-targeted therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years 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)

Progression Free Survival (PFS)

Secondary study objectives

Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)

Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)

Change from Baseline in Patient Global Impression of Change (PGIC)

+16 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: Standard Available Therapy (SAT)Experimental Treatment6 Interventions

Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).

Group II: ABBV-383Experimental Treatment1 Intervention

Participants will receive ABBV-383 as a monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elotuzumab

2016

Completed Phase 3

~950

Pomalidomide

2011