A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma (NCT05650632) — Spain Trial Details

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Etentamig (ABBV-383): Intravenous Infusion

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * 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). Exclusion Criteria: * Arm A: Received BCMA-targeted therapy. * Arm C and Arm D: Rapidly progressing disease per investigator.

Primary outcome measure(s)

Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events — Up to Day 28
CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS]) — Up to Day 28
AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Trial sites (46)

Facility	City	Region	Status
Mayo Clinic Arizona /ID# 251405	Phoenix	Arizona	Recruiting
Highlands Oncology Group - Springdale /ID# 267742	Springdale	Arkansas	Recruiting
Rocky Mountain Cancer Centers - Aurora /ID# 268574	Aurora	Colorado	Recruiting
Medical Oncology Hematology Consultants /ID# 268560	Newark	Delaware	Recruiting
Hope And Healing Cancer Services /ID# 268536	Hinsdale	Illinois	Recruiting
Fort Wayne Medical Oncology And Hematology /ID# 268179	Fort Wayne	Indiana	Recruiting
Franciscan St. Francis Health /ID# 280928	Indianapolis	Indiana	Recruiting
Tulane University School of Medicine /ID# 251204	New Orleans	Louisiana	Recruiting
Maryland Oncology Hematology - Silver Spring /ID# 268562	Silver Spring	Maryland	Not Yet Recruiting
Mayo Clinic - Rochester /ID# 251164	Rochester	Minnesota	Recruiting
NHO Revive Research Institute, LLC /ID# 267869	Lincoln	Nebraska	Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497	Omaha	Nebraska	Recruiting
Mt Sinai /ID# 251166	New York	New York	Recruiting
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167	New York	New York	Recruiting
University of North Carolina /ID# 251203	Chapel Hill	North Carolina	Recruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 251165	Winston-Salem	North Carolina	Recruiting
University Of Cincinnati Medical Center /ID# 251746	Cincinnati	Ohio	Recruiting
Willamette Valley Cancer Institute and Research Center /ID# 267088	Eugene	Oregon	Recruiting
Baptist Memorial Hospital /ID# 280677	Memphis	Tennessee	Not Yet Recruiting
Vanderbilt Ingram Cancer Center /ID# 252470	Nashville	Tennessee	Recruiting
Texas Oncology - Central/South Texas /ID# 268563	Austin	Texas	Recruiting
Texas Oncology - Dallas - Worth Street /ID# 280064	Dallas	Texas	Recruiting
Oncology Consultants /ID# 268323	Houston	Texas	Recruiting
Texas Oncology - Northeast Texas /ID# 268877	Tyler	Texas	Recruiting
Virginia Cancer Specialists - Fairfax /ID# 268559	Fairfax	Virginia	Recruiting
Fred Hutchinson Cancer Center. /ID# 267940	Seattle	Washington	Recruiting
Northwest Medical Specialties Tacoma /ID# 267117	Tacoma	Washington	Recruiting
Juravinski Cancer Centre /ID# 252053	Hamilton	Ontario	Recruiting
Ottawa Hospital Research Institute /ID# 252151	Ottawa	Ontario	Completed
Odense University Hospital /ID# 251261	Odense	Region Syddanmark	Recruiting
Vejle Sygehus /ID# 251260	Vejle	Region Syddanmark	Recruiting
Institut Paoli-Calmettes /ID# 252100	Marseille	Bouches-du-Rhone	Completed
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101	Créteil	Paris	Completed
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196	Nantes	Pays de la Loire Region	Recruiting
HCL - Hopital Lyon Sud /ID# 251223	Pierre-Bénite	Rhone	Recruiting
CHU Poitiers - La miletrie /ID# 251219	Poitiers	Vienne	Recruiting
AP-HP - Hopital Saint-Antoine /ID# 252326	Paris	France	Completed
Rabin Medical Center. /ID# 251330	Petah Tikva	Central District	Recruiting
Hadassah Medical Center-Hebrew University /ID# 252079	Jerusalem	Jerusalem	Recruiting
The Chaim Sheba Medical Center /ID# 251329	Ramat Gan	Tel Aviv	Recruiting

+ 6 more sites — see the full list on the official registry below.

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