Comparing Etentamig to Standard Therapies for Relapsed Multiple Myeloma
A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
This study is testing a new drug called etentamig to see if it works better than standard treatments for adults with relapsed multiple myeloma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 166 sites (Birmingham, Alabama and 165 other locations) |
| Trial ID | NCT06158841 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of etentamig, an investigational drug, as a monotherapy in adults with relapsed or refractory multiple myeloma (MM) compared to standard available therapies. Participants are divided into two arms: one receiving etentamig and the other receiving a standard therapy chosen by the investigator. The study aims to assess changes in disease symptoms and overall effectiveness of etentamig in this patient population. Eligible participants must have measurable disease and a history of multiple prior treatments.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with relapsed or refractory multiple myeloma who have undergone at least two prior lines of therapy.
Not a fit: Patients who have not received prior treatment for multiple myeloma or those with ECOG performance status greater than 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with relapsed or refractory multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar investigational therapies for multiple myeloma, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). * 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. Exclusion Criteria: * 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 this trial is running
Birmingham, Alabama and 165 other locations
- University of Alabama at Birmingham - Main /ID# 261434 — Birmingham, Alabama, United States (Recruiting)
- Mayo Clinic Hospital - Phoenix /ID# 263326 — Phoenix, Arizona, United States (Recruiting)
- Alta Bates Summit Medical Center for Research /ID# 261438 — Berkeley, California, United States (Completed)
- Providence - St. Jude Medical Center /ID# 262031 — Fullerton, California, United States (Recruiting)
- VA Loma Linda Healthcare System /ID# 261015 — Loma Linda, California, United States (Recruiting)
- Cedars-Sinai Medical Center /ID# 261008 — Los Angeles, California, United States (Recruiting)
- Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 — Lone Tree, Colorado, United States (Recruiting)
- Mayo Clinic Hospital Jacksonville /ID# 263324 — Jacksonville, Florida, United States (Recruiting)
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230 — Jacksonville, Florida, United States (Recruiting)
- Winship Cancer Institute of Emory University /ID# 262525 — Atlanta, Georgia, United States (Recruiting)
- University of Illinois Hospital and Health Sciences System /ID# 246349 — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Center /ID# 265690 — Chicago, Illinois, United States (Recruiting)
- Nancy W. Knowles Cancer Center /ID# 271361 — Elmhurst, Illinois, United States (Recruiting)
- Springfield Clinic - First /ID# 262266 — Springfield, Illinois, United States (Recruiting)
- Our Lady Of The Lake Regional Medical Center /ID# 272780 — Baton Rouge, Louisiana, United States (Recruiting)
- Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637 — Bethesda, Maryland, United States (Recruiting)
- Beth Israel Deaconess Medical Center /ID# 271535 — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute /ID# 261554 — Boston, Massachusetts, United States (Recruiting)
- Regents of the University of Michigan /ID# 261577 — Ann Arbor, Michigan, United States (Recruiting)
- Karmanos Cancer Institute - Detroit /ID# 266298 — Detroit, Michigan, United States (Recruiting)
- Henry Ford Hospital /ID# 262704 — Detroit, Michigan, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891 — Lansing, Michigan, United States (Recruiting)
- Mayo Clinic - Rochester /ID# 246228 — Rochester, Minnesota, United States (Recruiting)
- University of Missouri Hospital /ID# 261553 — Columbia, Missouri, United States (Recruiting)
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772 — Omaha, Nebraska, United States (Recruiting)
- New York Cancer & Blood Specialists - Bay Shore /ID# 261524 — Bay Shore, New York, United States (Recruiting)
- New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953 — New Hyde Park, New York, United States (Completed)
- New York Cancer and Blood Specialists - New York /ID# 262951 — New York, New York, United States (Completed)
- Eastchester Center for Cancer Care /ID# 262952 — The Bronx, New York, United States (Recruiting)
- University of North Carolina /ID# 259854 — Chapel Hill, North Carolina, United States (Recruiting)
- Atrium Health Levine Cancer Institute /ID# 246199 — Charlotte, North Carolina, United States (Recruiting)
- Duke University Medical Center /ID# 259694 — Durham, North Carolina, United States (Recruiting)
- University Of Cincinnati Medical Center /ID# 246415 — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic Main Campus /ID# 246183 — Cleveland, Ohio, United States (Recruiting)
- Oregon Medical Research Center /ID# 262335 — Portland, Oregon, United States (Recruiting)
- Medical University of South Carolina /ID# 259692 — Charleston, South Carolina, United States (Recruiting)
- University of Tennessee Health Science Center /ID# 261622 — Memphis, Tennessee, United States (Recruiting)
- Baptist Memorial Hospital /ID# 270910 — Memphis, Tennessee, United States (Recruiting)
- The West Clinic /ID# 262444 — Memphis, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center /ID# 261621 — Nashville, Tennessee, United States (Recruiting)
- Oncology Consultants /ID# 276774 — Houston, Texas, United States (Recruiting)
- Texas Oncology - Northeast Texas /ID# 278304 — Tyler, Texas, United States (Recruiting)
- Virginia Cancer Specialists - Fairfax /ID# 262792 — Fairfax, Virginia, United States (Recruiting)
- Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314 — Norfolk, Virginia, United States (Recruiting)
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944 — Richmond, Virginia, United States (Recruiting)
- Northwest Medical Specialties Tacoma /ID# 276281 — Tacoma, Washington, United States (Recruiting)
- St George Hospital /ID# 261806 — Kogarah, New South Wales, Australia (Recruiting)
- Liverpool Hospital /ID# 262159 — Liverpool, New South Wales, Australia (Recruiting)
- Calvary Mater Newcastle /ID# 261804 — Waratah, New South Wales, Australia (Recruiting)
- Princess Alexandra Hospital /ID# 261810 — Woolloongabba, Queensland, Australia (Recruiting)
+116 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.