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A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2023-03-21
Completion Date
2029-08
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Etentamig (ABBV-383)
Intravenous Infusion
Locations (41)
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