Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05650632

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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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

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