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

Last updated: January 28, 2025
Sponsor: TeneoOne Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer/tumors

Leukemia

Multiple Myeloma

Treatment

ABBV-383

Clinical Study ID

NCT05650632
M24-108
2023-504674-38-00
EU CT 2022-502399-21-00
  • Ages > 18
  • All Genders

Study 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 ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. 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 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 ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. "In Arm C, the step-up dose identified in Arm A will be used followed by the target dose of ABBV-383 to investigate outpatient administration of ABBV-383. Around 180 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 40 sites across the world.

Participants will receive 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have measurable disease as outlined in the protocol.

  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2. Arm C only: ECOGperformance of <= 1.

  • Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence ofprogression during or after the participant's last treatment regimen based on theinvestigator's determination of the International Myeloma Working Group (IMWG) 2016criteria.

  • Must be naïve to treatment with ABBV-383.

  • Arm A: Must have received at least 3 or more lines of therapy, including aproteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38monoclonal antibody.

  • Arm B: Must have received at least 2 or more lines of therapy, including exposure toa PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturationantigen (BCMA)-targeted therapy (must be an anti-drug conjugate [ADC] or chimericantigen receptor T-cell [CAR-T] directed against BCMA).

  • Arm C: Must have received at least 2 or more lines of therapy, including exposure toa PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatientadministration of ABBV-383.

Exclusion

Exclusion Criteria:

  • Arm A: Received BCMA-targeted therapy.

  • Arm C: Rapidly progressing disease per investigator.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: ABBV-383
Phase: 1
Study Start date:
March 21, 2023
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Tom Baker Cancer Centre /ID# 252058

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute /ID# 252056

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Juravinski Cancer Centre /ID# 252053

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute /ID# 252151

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Odense University Hospital /ID# 251261

    Odense, Syddanmark 5000
    Denmark

    Active - Recruiting

  • Odense Universitets Hospital /ID# 251261

    Odense C, Syddanmark 5000
    Denmark

    Site Not Available

  • Sygehus Lillebalt, Vejle /ID# 251260

    Vejle, Syddanmark 7100
    Denmark

    Active - Recruiting

  • Institut Paoli-Calmettes /ID# 252100

    Marseille, Bouches-du-Rhone 13009
    France

    Active - Recruiting

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

    Creteil, Paris 94010
    France

    Active - Recruiting

  • CHU de Nantes, Hotel Dieu -HME /ID# 251196

    Nantes, Pays-de-la-Loire 44000
    France

    Active - Recruiting

  • HCL - Hopital Lyon Sud /ID# 251223

    Pierre Benite CEDEX, Rhone 69495
    France

    Active - Recruiting

  • CHU Poitiers - La miletrie /ID# 251219

    Poitiers, Vienne 86000
    France

    Active - Recruiting

  • Hopital Henri Mondor /ID# 252101

    Creteil, 94000
    France

    Site Not Available

  • Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 252101

    Créteil, 94010
    France

    Site Not Available

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

    Paris, 75012
    France

    Active - Recruiting

  • Institut Claudius Regaud /ID# 252099

    Toulouse, 31052
    France

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 251329

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 251573

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 251573

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 252079

    Jerusalem, Yerushalayim 91120
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 251330

    Haifa, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 251330

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 251330

    Petakh Tikva, 4941492
    Israel

    Site Not Available

  • Hospital Universitario Marques de Valdecilla /ID# 251528

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Unversitario Marques de Valdecilla /ID# 251528

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545

    Majadahonda, Madrid 28222
    Spain

    Completed

  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 251545

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca /ID# 251529

    Salamanca, 37711
    Spain

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust /ID# 251357

    London, Greater London NW1 2PG
    United Kingdom

    Active - Recruiting

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 251354

    Norwich, Norfolk NR4 7UY
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust /ID# 251358

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • NHS Lothian /ID# 252060

    Edinburgh, EH3 9HE
    United Kingdom

    Site Not Available

  • The Christie Hospital /ID# 251774

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Mayo Clinic Arizona /ID# 251405

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Highlands Oncology Group - Springdale /ID# 267742

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers - Aurora /ID# 268574

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Medical Oncology Hematology Consultants /ID# 268560

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Hope And Healing Cancer Services /ID# 268536

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology And Hematology /ID# 268179

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Tulane University /ID# 251204

    New Orleans, Louisiana 70112-2005
    United States

    Site Not Available

  • Tulane University School of Medicine /ID# 251204

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester /ID# 251164

    Rochester, Minnesota 55905-0001
    United States

    Active - Recruiting

  • NHO Revive Research Institute, LLC /ID# 267869

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

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

    New York, New York 10065-6007
    United States

    Active - Recruiting

  • Mt Sinai /ID# 251166

    New York, New York 10029-6542
    United States

    Active - Recruiting

  • University of North Carolina /ID# 251203

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Wake Forest Univ HS /ID# 251165

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • University Of Cincinnati Medical Center /ID# 251746

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Cincinnati /ID# 251746

    Cincinnati, Ohio 45267-0585
    United States

    Active - Recruiting

  • Vanderbilt Ingram Cancer Center /ID# 252470

    Nashville, Tennessee 37232-0021
    United States

    Active - Recruiting

  • Texas Oncology - Central/South Texas /ID# 268563

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Oncology Consultants /ID# 268323

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Oncology - Northeast Texas /ID# 268877

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Virginia Cancer Specialists - Fairfax /ID# 268559

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Northwest Medical Specialties Tacoma /ID# 267117

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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