Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

Recruiting now · Phase 3

Conditions studied: Multiple Myeloma

In brief

Multiple myeloma (MM) is a cancer of the blood's plasma cells. 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 change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. 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

NCT06158841

Run by

AbbVie

People needed

380

Starts

2024-05-19

Expected to finish

2027-12-01

Last updated by the study team

2026-08-03

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
• Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
• Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
• Serum M-protein >= 0.5 g/dL (>= 5 g/L).
• Urine M-protein >= 200 mg/24 hours.
• In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
• Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
• - US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.
• Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.

You may not qualify if…

• Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
• Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
• Central nervous system involvement of MM.
• Has received B-cell maturation antigen (BCMA)-targeted therapy.

Where it is running

• New York Cancer & Blood Specialists - Bay Shore /ID# 261524 — Bay Shore, New York, United States (enrolling)
• Atrium Health Levine Cancer Institute /ID# 246199 — Charlotte, North Carolina, United States (enrolling)
• Providence - St. Jude Medical Center /ID# 262031 — Fullerton, California, United States (enrolling)
• Mayo Clinic Hospital - Phoenix /ID# 263326 — Phoenix, Arizona, United States (enrolling)
• Eastchester Center for Cancer Care /ID# 262952 — The Bronx, New York, United States (enrolling)
• University of North Carolina /ID# 259854 — Chapel Hill, North Carolina, United States (enrolling)
• Mayo Clinic Hospital Jacksonville /ID# 263324 — Jacksonville, Florida, United States (enrolling)
• Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230 — Jacksonville, Florida, United States (enrolling)
• VA Loma Linda Healthcare System /ID# 261015 — Loma Linda, California, United States (enrolling)
• University of Illinois Hospital and Health Sciences System /ID# 246349 — Chicago, Illinois, United States (enrolling)
• University of Alabama at Birmingham - Main /ID# 261434 — Birmingham, Alabama, United States (enrolling)
• Nancy W. Knowles Cancer Center /ID# 271361 — Elmhurst, Illinois, United States (enrolling)
• Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 — Lone Tree, Colorado, United States (enrolling)
• Our Lady Of The Lake Regional Medical Center /ID# 272780 — Baton Rouge, Louisiana, United States (enrolling)
• Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637 — Bethesda, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center /ID# 271535 — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute /ID# 261554 — Boston, Massachusetts, United States (enrolling)
• Regents of the University of Michigan /ID# 261577 — Ann Arbor, Michigan, United States (enrolling)
• Karmanos Cancer Institute - Detroit /ID# 266298 — Detroit, Michigan, United States (enrolling)
• Winship Cancer Institute of Emory University /ID# 262525 — Atlanta, Georgia, United States (enrolling)
• Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891 — Lansing, Michigan, United States (enrolling)
• Mayo Clinic - Rochester /ID# 246228 — Rochester, Minnesota, United States (enrolling)
• Cedars-Sinai Medical Center /ID# 261008 — Los Angeles, California, United States (enrolling)
• Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772 — Omaha, Nebraska, United States (enrolling)
• Cleveland Clinic Main Campus /ID# 246183 — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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