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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Etentamig (ABBV-383)

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Recruiting
      • Juravinski Cancer Centre /ID# 252053
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Ottawa Hospital Research Institute /ID# 252151
• Denmark
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Recruiting
      • Odense University Hospital /ID# 251261
    • Vejle, Region Syddanmark, Denmark, 7100
      • Recruiting
      • Vejle Sygehus /ID# 251260
• France
  • Paris, France, 75012
    • Completed
    • AP-HP - Hopital Saint-Antoine /ID# 252326
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13009
      • Completed
      • Institut Paoli-Calmettes /ID# 252100
  • Paris
    • Créteil, Paris, France, 94010
      • Completed
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • Recruiting
      • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196
  • Rhone
    • Pierre-Bénite, Rhone, France, 69495
      • Recruiting
      • HCL - Hopital Lyon Sud /ID# 251223
  • Vienne
    • Poitiers, Vienne, France, 86000
      • Recruiting
      • CHU Poitiers - La miletrie /ID# 251219
• Israel
  • Central District
    • Petah Tikva, Central District, Israel, 4941492
      • Recruiting
      • Rabin Medical Center. /ID# 251330
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91120
      • Recruiting
      • Hadassah Medical Center-Hebrew University /ID# 252079
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • Recruiting
      • The Chaim Sheba Medical Center /ID# 251329
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Recruiting
      • Tel Aviv Sourasky Medical Center /ID# 251573
• Spain
  • Salamanca, Spain, 37711
    • Recruiting
    • Hospital Universitario de Salamanca /ID# 251529
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla /ID# 251528
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Completed
      • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545
• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie Hospital /ID# 251774
    • Contact: Site Coordinator; Phone Number: 0161 446 3285
  • Greater London
    • London, Greater London, United Kingdom, NW1 2BU
      • Recruiting
      • University College London Hospital /ID# 251357
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona /ID# 251405
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Recruiting
      • Highlands Oncology Group - Springdale /ID# 267742
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Recruiting
      • Rocky Mountain Cancer Centers - Aurora /ID# 268574
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Medical Oncology Hematology Consultants /ID# 268560
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • Hope And Healing Cancer Services /ID# 268536
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Medical Oncology And Hematology /ID# 268179
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University School of Medicine /ID# 251204
  • Maryland
    • Silver Spring, Maryland, United States, 20904
      • Not yet recruiting
      • Maryland Oncology Hematology - Silver Spring /ID# 268562
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic - Rochester /ID# 251164
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • NHO Revive Research Institute, LLC /ID# 267869
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497
  • New York
    • New York, New York, United States, 10065-6007
      • Recruiting
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
    • New York, New York, United States, 10029-6542
      • Recruiting
      • Mt Sinai /ID# 251166
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina /ID# 251203
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist Medical Center /ID# 251165
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University Of Cincinnati Medical Center /ID# 251746
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Willamette Valley Cancer Institute and Research Center /ID# 267088
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Not yet recruiting
      • Baptist Memorial Hospital /ID# 280677
    • Nashville, Tennessee, United States, 37232-0021
      • Recruiting
      • Vanderbilt Ingram Cancer Center /ID# 252470
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Oncology - Central/South Texas /ID# 268563
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Texas Oncology - Dallas - Worth Street /ID# 280064
    • Houston, Texas, United States, 77030
      • Recruiting
      • Oncology Consultants /ID# 268323
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast Texas /ID# 268877
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists - Fairfax /ID# 268559
  • Washington
    • Seattle, Washington, United States, 98109-4405
      • Recruiting
      • Fred Hutchinson Cancer Center. /ID# 267940
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties Tacoma /ID# 267117

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Etentamig (ABBV-383); Intravenous Infusion
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.	Drug: Etentamig (ABBV-383); Intravenous Infusion
Experimental: Arm B: ABBV-383 BCMA Exposed; Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.	Drug: Etentamig (ABBV-383); Intravenous Infusion
Experimental: Arm C: ABBV-383 Step Up; Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.	Drug: Etentamig (ABBV-383); Intravenous Infusion
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.	Drug: Etentamig (ABBV-383); Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 28
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	Up to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm A, Arm C. and Arm D: Number of 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	Up to 3 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Multiple Myeloma; ABBV-383; B-Cell Maturation Antigen
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Neoplasms; Multiple Myeloma
• Other Study ID Numbers: M24-108; 2023-504674-38-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No