Actively Recruiting
A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma
Led by AbbVie · Updated on 2026-05-13
210
Participants Needed
42
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have measurable disease as outlined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. For Arms C and D, ECOG performance status of 1 or less.
- Relapsed or refractory multiple myeloma with documented progression after last treatment based on International Myeloma Working Group 2016 criteria.
- No previous treatment with etentamig (ABBV-383).
- Arm A: At least 3 prior therapies including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
- Arm B: At least 2 prior therapies including exposure to a proteasome inhibitor, an immunomodulatory drug, an anti-CD38 antibody, and prior B-cell maturation antigen-targeted therapy (antibody drug conjugate or CAR-T).
- Arm C: At least 2 prior therapies including exposure to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody, and suitable for outpatient etentamig administration.
- Arm D: Between 1 and 3 prior therapies including exposure to a proteasome inhibitor, an immunomodulatory drug, or an anti-CD38 antibody, and suitable for outpatient etentamig administration.
You will not qualify if you...
- Arm A: Prior treatment with B-cell maturation antigen-targeted therapy.
- Arms C and D: Rapidly progressing disease as determined by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Mayo Clinic Arizona /ID# 251405
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Highlands Oncology Group - Springdale /ID# 267742
Springdale, Arkansas, United States, 72762
Actively Recruiting
3
Rocky Mountain Cancer Centers - Aurora /ID# 268574
Aurora, Colorado, United States, 80012
Actively Recruiting
4
Medical Oncology Hematology Consultants /ID# 268560
Newark, Delaware, United States, 19713
Actively Recruiting
5
Hope And Healing Cancer Services /ID# 268536
Hinsdale, Illinois, United States, 60521
Actively Recruiting
6
Fort Wayne Medical Oncology And Hematology /ID# 268179
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
7
Tulane University School of Medicine /ID# 251204
New Orleans, Louisiana, United States, 70112
Actively Recruiting
8
Mayo Clinic - Rochester /ID# 251164
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
9
NHO Revive Research Institute, LLC /ID# 267869
Lincoln, Nebraska, United States, 68506
Actively Recruiting
10
Mt Sinai /ID# 251166
New York, New York, United States, 10029-6542
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
New York, New York, United States, 10065-6007
Actively Recruiting
12
University of North Carolina /ID# 251203
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
13
Atrium Health Wake Forest Baptist Medical Center /ID# 251165
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
14
University Of Cincinnati Medical Center /ID# 251746
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
Willamette Valley Cancer Institute and Research Center /ID# 267088
Eugene, Oregon, United States, 97401
Actively Recruiting
16
Vanderbilt Ingram Cancer Center /ID# 252470
Nashville, Tennessee, United States, 37232-0021
Actively Recruiting
17
Texas Oncology - Central/South Texas /ID# 268563
Austin, Texas, United States, 78705
Actively Recruiting
18
Texas Oncology - Dallas - Worth Street /ID# 280064
Dallas, Texas, United States, 75246
Actively Recruiting
19
Oncology Consultants /ID# 268323
Houston, Texas, United States, 77030
Actively Recruiting
20
Texas Oncology - Northeast Texas /ID# 268877
Tyler, Texas, United States, 75702
Actively Recruiting
21
Virginia Cancer Specialists - Fairfax /ID# 268559
Fairfax, Virginia, United States, 22031
Actively Recruiting
22
Fred Hutchinson Cancer Center. /ID# 267940
Seattle, Washington, United States, 98109-4405
Actively Recruiting
23
Northwest Medical Specialties Tacoma /ID# 267117
Tacoma, Washington, United States, 98405
Actively Recruiting
24
Juravinski Cancer Centre /ID# 252053
Hamilton, Ontario, Canada, L8V 1C3
Actively Recruiting
25
Ottawa Hospital Research Institute /ID# 252151
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
26
Odense University Hospital /ID# 251261
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
27
Vejle Sygehus /ID# 251260
Vejle, Region Syddanmark, Denmark, 7100
Actively Recruiting
28
Institut Paoli-Calmettes /ID# 252100
Marseille, Bouches-du-Rhone, France, 13009
Completed
29
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101
Créteil, Paris, France, 94010
Completed
30
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
31
HCL - Hopital Lyon Sud /ID# 251223
Pierre-Bénite, Rhone, France, 69495
Actively Recruiting
32
CHU Poitiers - La miletrie /ID# 251219
Poitiers, Vienne, France, 86000
Actively Recruiting
33
AP-HP - Hopital Saint-Antoine /ID# 252326
Paris, France, 75012
Completed
34
Rabin Medical Center. /ID# 251330
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
35
Hadassah Medical Center-Hebrew University /ID# 252079
Jerusalem, Jerusalem, Israel, 91120
Actively Recruiting
36
The Chaim Sheba Medical Center /ID# 251329
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
37
Tel Aviv Sourasky Medical Center /ID# 251573
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
38
Hospital Universitario Marques de Valdecilla /ID# 251528
Santander, Cantabria, Spain, 39008
Actively Recruiting
39
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545
Majadahonda, Madrid, Spain, 28222
Completed
40
Hospital Universitario de Salamanca /ID# 251529
Salamanca, Spain, 37711
Actively Recruiting
41
University College London Hospital /ID# 251357
London, Greater London, United Kingdom, NW1 2BU
Actively Recruiting
42
The Christie Hospital /ID# 251774
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here