Recruiting
Phase 1

ABBV-383

Sponsor:

AbbVie

Code:

NCT05650632

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Etentamig (ABBV-383)

Study Details

Brief summary:

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). Around 210 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.

Conditions

Multiple Myeloma

Study ID

NCT05650632

Start date

Mar 21, 2023

Status verified date

Jul, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must have measurable disease as outlined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2. Arm C and Arm D: ECOG performance of <= 1.
  • Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
  • Must be naïve to treatment with etentamig (ABBV-383).
  • Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
  • Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
  • Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
  • Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).

Exclusion Criteria:

  • Arm A: Received BCMA-targeted therapy.
  • Arm C and Arm D: Rapidly progressing disease per investigator.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (Part 1): ABBV-383 Dose Escalation

B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.

experimental: Arm A (Part 2): ABBV-383 Dose Expansion

BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.

experimental: Arm B: ABBV-383 BCMA Exposed

Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.

experimental: Arm C: ABBV-383 Step Up

Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

experimental: Arm D: ABBV-383 Step Up

Participants who have received at least 1 and no more than 3 prior lines of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

Interventions

Etentamig (ABBV-383)

Intravenous Infusion

Primary outcome measure

  • Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to Day 28 ]
  • Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS]) [ Time Frame: Up to Day 28 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Mayo Clinic Arizona /ID# 251405

Recruiting

Phoenix, Arizona, United States, 85054

Highlands Oncology Group - Springdale /ID# 267742

Recruiting

Springdale, Arkansas, United States, 72762

Rocky Mountain Cancer Centers - Aurora /ID# 268574

Recruiting

Aurora, Colorado, United States, 80012

Medical Oncology Hematology Consultants /ID# 268560

Recruiting

Newark, Delaware, United States, 19713

Hope And Healing Cancer Services /ID# 268536

Recruiting

Hinsdale, Illinois, United States, 60521

Fort Wayne Medical Oncology And Hematology /ID# 268179

Recruiting

Fort Wayne, Indiana, United States, 46804

Franciscan St. Francis Health /ID# 280928

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Site Coordinator

317-528-8538kathleen.novak@franciscanalliance.org

Tulane University School of Medicine /ID# 251204

Recruiting

New Orleans, Louisiana, United States, 70112

Mayo Clinic - Rochester /ID# 251164

Recruiting

Rochester, Minnesota, United States, 55905-0001

NHO Revive Research Institute, LLC /ID# 267869

Recruiting

Lincoln, Nebraska, United States, 68506

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497

Recruiting

Omaha, Nebraska, United States, 68130

Mt Sinai /ID# 251166

Recruiting

New York, New York, United States, 10029-6542

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167

Recruiting

New York, New York, United States, 10065-6007

University of North Carolina /ID# 251203

Recruiting

Chapel Hill, North Carolina, United States, 27514

Atrium Health Wake Forest Baptist Medical Center /ID# 251165

Recruiting

Winston-Salem, North Carolina, United States, 27157

University Of Cincinnati Medical Center /ID# 251746

Recruiting

Cincinnati, Ohio, United States, 45219

Willamette Valley Cancer Institute and Research Center /ID# 267088

Recruiting

Eugene, Oregon, United States, 97401

Vanderbilt Ingram Cancer Center /ID# 252470

Recruiting

Nashville, Tennessee, United States, 37232-0021

Texas Oncology - Central/South Texas /ID# 268563

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Dallas - Worth Street /ID# 280064

Recruiting

Dallas, Texas, United States, 75246

Oncology Consultants /ID# 268323

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Northeast Texas /ID# 268877

Recruiting

Tyler, Texas, United States, 75702

Virginia Cancer Specialists - Fairfax /ID# 268559

Recruiting

Fairfax, Virginia, United States, 22031

Fred Hutchinson Cancer Center. /ID# 267940

Recruiting

Seattle, Washington, United States, 98109-4405

Northwest Medical Specialties Tacoma /ID# 267117

Recruiting

Tacoma, Washington, United States, 98405

Juravinski Cancer Centre /ID# 252053

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

More Information

Sponsor

AbbVie

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Multiple Myeloma
  • Cancer
  • ABBV-383
  • B-Cell Maturation Antigen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.