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

NCT05650632 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: M24-1082023-504674-38-00
• Study Type: interventional
• Target: 210
• Locations: 7 countries
• Sites: 41

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events

  Up to 3 Years

Study Arms (5)

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

EXPERIMENTAL

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

Drug: Etentamig (ABBV-383)

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

EXPERIMENTAL

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

Drug: Etentamig (ABBV-383)

Arm B: ABBV-383 BCMA Exposed

EXPERIMENTAL

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

Drug: Etentamig (ABBV-383)

Arm C: ABBV-383 Step Up

EXPERIMENTAL

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

Drug: Etentamig (ABBV-383)

Arm D: ABBV-383 Step Up

EXPERIMENTAL

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)

Interventions

Etentamig (ABBV-383) DRUG

Intravenous Infusion

Arm A (Part 1): ABBV-383 Dose Escalation; Arm A (Part 2): ABBV-383 Dose Expansion; Arm B: ABBV-383 BCMA Exposed; Arm C: ABBV-383 Step Up; Arm D: ABBV-383 Step Up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (41)

Mayo Clinic Arizona /ID# 251405

Phoenix, Arizona, 85054, United States

RECRUITING

Highlands Oncology Group - Springdale /ID# 267742

Springdale, Arkansas, 72762, United States

RECRUITING

Rocky Mountain Cancer Centers - Aurora /ID# 268574

Aurora, Colorado, 80012, United States

RECRUITING

Medical Oncology Hematology Consultants /ID# 268560

Newark, Delaware, 19713, United States

RECRUITING

Hope And Healing Cancer Services /ID# 268536

Hinsdale, Illinois, 60521, United States

RECRUITING

Fort Wayne Medical Oncology And Hematology /ID# 268179

Fort Wayne, Indiana, 46804, United States

RECRUITING

Tulane University School of Medicine /ID# 251204

New Orleans, Louisiana, 70112, United States

RECRUITING

Mayo Clinic - Rochester /ID# 251164

Rochester, Minnesota, 55905-0001, United States

RECRUITING

NHO Revive Research Institute, LLC /ID# 267869

Lincoln, Nebraska, 68506, United States

RECRUITING

Mt Sinai /ID# 251166

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

RECRUITING

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

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

RECRUITING

University of North Carolina /ID# 251203

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center /ID# 251165

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University Of Cincinnati Medical Center /ID# 251746

Cincinnati, Ohio, 45219, United States

RECRUITING

Willamette Valley Cancer Institute and Research Center /ID# 267088

Eugene, Oregon, 97401, United States

RECRUITING

Vanderbilt Ingram Cancer Center /ID# 252470

Nashville, Tennessee, 37232-0021, United States

RECRUITING

Texas Oncology - Central/South Texas /ID# 268563

Austin, Texas, 78705, United States

RECRUITING

Oncology Consultants /ID# 268323

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Northeast Texas /ID# 268877

Tyler, Texas, 75702, United States

RECRUITING

Virginia Cancer Specialists - Fairfax /ID# 268559

Fairfax, Virginia, 22031, United States

RECRUITING

Fred Hutchinson Cancer Center. /ID# 267940

Seattle, Washington, 98109-4405, United States

RECRUITING

Northwest Medical Specialties Tacoma /ID# 267117

Tacoma, Washington, 98405, United States

RECRUITING

Juravinski Cancer Centre /ID# 252053

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Ottawa Hospital Research Institute /ID# 252151

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Odense University Hospital /ID# 251261

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Vejle Sygehus /ID# 251260

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

Institut Paoli-Calmettes /ID# 252100

Marseille, Bouches-du-Rhone, 13009, France

COMPLETED

Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101

Créteil, Paris, 94010, France

COMPLETED

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196

Nantes, Pays de la Loire Region, 44000, France

RECRUITING

HCL - Hopital Lyon Sud /ID# 251223

Pierre-Bénite, Rhone, 69495, France

RECRUITING

CHU Poitiers - La miletrie /ID# 251219

Poitiers, Vienne, 86000, France

RECRUITING

AP-HP - Hopital Saint-Antoine /ID# 252326

Paris, 75012, France

COMPLETED

Hadassah Medical Center-Hebrew University /ID# 252079

Jerusalem, Jerusalem, 91120, Israel

RECRUITING

The Chaim Sheba Medical Center /ID# 251329

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 251573

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

Rabin Medical Center. /ID# 251330

Petah Tikva, 4941492, Israel

RECRUITING

Hospital Universitario Marques de Valdecilla /ID# 251528

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545

Majadahonda, Madrid, 28222, Spain

COMPLETED

Hospital Universitario de Salamanca /ID# 251529

Salamanca, 37711, Spain

RECRUITING

University College London Hospital /ID# 251357

London, Greater London, NW1 2BU, United Kingdom

RECRUITING

The Christie Hospital /ID# 251774

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: March 21, 2023
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (22); IL (4); FR (6); ES (3); GB (2); DK (2)