A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma

ClinicalTrials.gov ID: NCT05650632

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Official title

A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). In Arm E, etentamig (ABBV-383) will be investigated for outpatient administration. Around 250 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world. Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Study identification

NCT ID: NCT05650632
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: AbbVie; Industry
Enrollment: 250 participants

Conditions and interventions

Conditions

Multiple Myeloma

Interventions

Etentamig (ABBV-383) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 21, 2023 (Actual)
Primary completion: Aug 2029 (Estimated)
Completion: Aug 2029 (Estimated)
Last update posted: Nov 10, 2026

2023 – 2029

United States locations

U.S. sites: 25
U.S. states: 17
U.S. cities: 24

Facility	City	State	ZIP	Site status
Mayo Clinic Arizona /ID# 251405	Phoenix	Arizona	85054	Recruiting
Highlands Oncology Group - Springdale /ID# 267742	Springdale	Arkansas	72762	Recruiting
Rocky Mountain Cancer Centers - Aurora /ID# 268574	Aurora	Colorado	80012	Recruiting
Medical Oncology Hematology Consultants /ID# 268560	Newark	Delaware	19713	Recruiting
Hope And Healing Cancer Services /ID# 268536	Hinsdale	Illinois	60521	Recruiting
Fort Wayne Medical Oncology And Hematology /ID# 268179	Fort Wayne	Indiana	46804	Recruiting
Franciscan St. Francis Health /ID# 280928	Indianapolis	Indiana	46237	Recruiting
East Jefferson General Hospital /ID# 251204	Metairie	Louisiana	70006	Recruiting
Mayo Clinic - Rochester /ID# 251164	Rochester	Minnesota	55905-0001	Recruiting
NHO Revive Research Institute, LLC /ID# 267869	Lincoln	Nebraska	68506	Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497	Omaha	Nebraska	68130	Recruiting
Icahn School of Medicine at Mount Sinai /ID# 251166	New York	New York	10029	Recruiting
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167	New York	New York	10065-6007	Recruiting
University of North Carolina /ID# 251203	Chapel Hill	North Carolina	27514	Recruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 251165	Winston-Salem	North Carolina	27157	Recruiting
University Of Cincinnati Medical Center /ID# 251746	Cincinnati	Ohio	45219	Recruiting
Willamette Valley Cancer Institute and Research Center /ID# 267088	Eugene	Oregon	97401	Recruiting
Vanderbilt Ingram Cancer Center /ID# 252470	Nashville	Tennessee	37232-0021	Recruiting
Texas Oncology - Central/South Texas /ID# 268563	Austin	Texas	78705	Recruiting
Texas Oncology - Dallas - Worth Street /ID# 280064	Dallas	Texas	75246	Recruiting
Oncology Consultants /ID# 268323	Houston	Texas	77030	Recruiting
Texas Oncology - Northeast Texas /ID# 268877	Tyler	Texas	75702	Recruiting
Virginia Cancer Specialists - Fairfax /ID# 268559	Fairfax	Virginia	22031	Recruiting
Fred Hutchinson Cancer Center - Seattle - Eastlake Avenue East /ID# 267940	Seattle	Washington	98109-4405	Recruiting
Northwest Medical Specialties Tacoma /ID# 267117	Tacoma	Washington	98405	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05650632, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 10, 2026 · Synced Nov 14, 2026