RecruitingInterventionalPhase 1

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

NCT ID: NCT05650632Sponsor: AbbVieLast updated: 2026-06-05

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.

Arms & interventions

DrugEtentamig (ABBV-383)
Intravenous Infusion

Outcome measures

Primary

Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events
CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
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])
AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: Up to Day 28

Secondary

Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events
Time frame: Up to 3 Years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (26)

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

Tulane University School of Medicine /ID# 251204

New Orleans, Louisiana, 70112

Recruiting

Maryland Oncology Hematology - Silver Spring /ID# 268562

Silver Spring, Maryland, 20904

Not Yet 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

Mt Sinai /ID# 251166

New York, New York, 10029-6542

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

Baptist Memorial Hospital /ID# 280677

Memphis, Tennessee, 38120

Not Yet 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. /ID# 267940

Seattle, Washington, 98109-4405

Recruiting

Northwest Medical Specialties Tacoma /ID# 267117

Tacoma, Washington, 98405

Recruiting