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

Recruiting now · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT05650632
Run by: AbbVie
People needed: 210
Starts: 2023-03-21
Expected to finish: 2029-08-01
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must have measurable disease as outlined in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance of <= 2. Arm C and Arm D: 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 etentamig (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 etentamig (ABBV-383).
Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).

You may not qualify if…

Arm A: Received BCMA-targeted therapy.
Arm C and Arm D: Rapidly progressing disease per investigator.

Where it is running

NHO Revive Research Institute, LLC /ID# 267869 — Lincoln, Nebraska, United States (enrolling)
Highlands Oncology Group - Springdale /ID# 267742 — Springdale, Arkansas, United States (enrolling)
Rocky Mountain Cancer Centers - Aurora /ID# 268574 — Aurora, Colorado, United States (enrolling)
Medical Oncology Hematology Consultants /ID# 268560 — Newark, Delaware, United States (enrolling)
Hope And Healing Cancer Services /ID# 268536 — Hinsdale, Illinois, United States (enrolling)
Fort Wayne Medical Oncology And Hematology /ID# 268179 — Fort Wayne, Indiana, United States (enrolling)
Franciscan St. Francis Health /ID# 280928 — Indianapolis, Indiana, United States (enrolling)
Tulane University School of Medicine /ID# 251204 — New Orleans, Louisiana, United States (enrolling)
Hadassah Medical Center-Hebrew University /ID# 252079 — Jerusalem, Jerusalem, Israel (enrolling)
The Chaim Sheba Medical Center /ID# 251329 — Ramat Gan, Tel Aviv, Israel (enrolling)
Tel Aviv Sourasky Medical Center /ID# 251573 — Tel Aviv, Tel Aviv, Israel (enrolling)
Hospital Universitario Marques de Valdecilla /ID# 251528 — Santander, Cantabria, Spain (enrolling)
Hospital Universitario de Salamanca /ID# 251529 — Salamanca, Spain (enrolling)
University College London Hospital /ID# 251357 — London, Greater London, United Kingdom (enrolling)
The Christie Hospital /ID# 251774 — Manchester, United Kingdom (enrolling)
Mayo Clinic - Rochester /ID# 251164 — Rochester, Minnesota, United States (enrolling)
Mayo Clinic Arizona /ID# 251405 — Phoenix, Arizona, United States (enrolling)
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497 — Omaha, Nebraska, United States (enrolling)
Mt Sinai /ID# 251166 — New York, New York, United States (enrolling)
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167 — New York, New York, United States (enrolling)
University of North Carolina /ID# 251203 — Chapel Hill, North Carolina, United States (enrolling)
Atrium Health Wake Forest Baptist Medical Center /ID# 251165 — Winston-Salem, North Carolina, United States (enrolling)
University Of Cincinnati Medical Center /ID# 251746 — Cincinnati, Ohio, United States (enrolling)
Willamette Valley Cancer Institute and Research Center /ID# 267088 — Eugene, Oregon, United States (enrolling)
Vanderbilt Ingram Cancer Center /ID# 252470 — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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