A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT05650632
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
180 participants
INTERVENTIONAL
2023-03-21
2029-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
ABBV-383
Intravenous Infusion
Arm A (Part 2): ABBV-383 Dose Expansion
BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.
ABBV-383
Intravenous Infusion
Arm B: ABBV-383 BCMA Exposed
Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.
ABBV-383
Intravenous Infusion
Arm C: ABBV-383 Step Up
Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
ABBV-383
Intravenous Infusion
Interventions
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ABBV-383
Intravenous Infusion
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C only: 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 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 ABBV-383.
Exclusion Criteria
* Arm C: Rapidly progressing disease per investigator.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Mayo Clinic Arizona /ID# 251405
Phoenix, Arizona, United States
Highlands Oncology Group - Springdale /ID# 267742
Springdale, Arkansas, United States
Rocky Mountain Cancer Centers - Aurora /ID# 268574
Aurora, Colorado, United States
Medical Oncology Hematology Consultants /ID# 268560
Newark, Delaware, United States
Hope And Healing Cancer Services /ID# 268536
Hinsdale, Illinois, United States
Fort Wayne Medical Oncology And Hematology /ID# 268179
Fort Wayne, Indiana, United States
Tulane University School of Medicine /ID# 251204
New Orleans, Louisiana, United States
Mayo Clinic - Rochester /ID# 251164
Rochester, Minnesota, United States
NHO Revive Research Institute, LLC /ID# 267869
Lincoln, Nebraska, United States
Mt Sinai /ID# 251166
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
New York, New York, United States
University of North Carolina /ID# 251203
Chapel Hill, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 251165
Winston-Salem, North Carolina, United States
University Of Cincinnati Medical Center /ID# 251746
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center /ID# 267088
Eugene, Oregon, United States
Vanderbilt Ingram Cancer Center /ID# 252470
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas /ID# 268563
Austin, Texas, United States
Oncology Consultants /ID# 268323
Houston, Texas, United States
Texas Oncology - Northeast Texas /ID# 268877
Tyler, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 268559
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center. /ID# 267940
Seattle, Washington, United States
Northwest Medical Specialties Tacoma /ID# 267117
Tacoma, Washington, United States
Juravinski Cancer Centre /ID# 252053
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute /ID# 252151
Ottawa, Ontario, Canada
Odense University Hospital /ID# 251261
Odense, Region Syddanmark, Denmark
Vejle Sygehus /ID# 251260
Vejle, Region Syddanmark, Denmark
Institut Paoli-Calmettes /ID# 252100
Marseille, Bouches-du-Rhone, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101
Créteil, Paris, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196
Nantes, Pays de la Loire Region, France
HCL - Hopital Lyon Sud /ID# 251223
Pierre-Bénite, Rhone, France
CHU Poitiers - La miletrie /ID# 251219
Poitiers, Vienne, France
AP-HP - Hopital Saint-Antoine /ID# 252326
Paris, , France
Hadassah Medical Center-Hebrew University /ID# 252079
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 251329
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 251573
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center /ID# 251330
Petah Tikva, , Israel
Hospital Universitario Marques de Valdecilla /ID# 251528
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545
Majadahonda, Madrid, Spain
Hospital Universitario de Salamanca /ID# 251529
Salamanca, , Spain
University College London Hospital /ID# 251357
London, Greater London, United Kingdom
The Christie Hospital /ID# 251774
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2023-504674-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
M24-108
Identifier Type: -
Identifier Source: org_study_id