Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (NCT06158841)
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)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham - Main /ID# 261434 โ Birmingham, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (166 Sites)
Showing the first 25 of 166 sites.
- University of Alabama at Birmingham - Main /ID# 261434 โ Birmingham, Alabama
- Mayo Clinic Hospital - Phoenix /ID# 263326 โ Phoenix, Arizona
- Alta Bates Summit Medical Center for Research /ID# 261438 โ Berkeley, California
- Providence - St. Jude Medical Center /ID# 262031 โ Fullerton, California
- VA Loma Linda Healthcare System /ID# 261015 โ Loma Linda, California
- Cedars-Sinai Medical Center /ID# 261008 โ Los Angeles, California
- Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 โ Lone Tree, Colorado
- Mayo Clinic Hospital Jacksonville /ID# 263324 โ Jacksonville, Florida
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230 โ Jacksonville, Florida
- Winship Cancer Institute of Emory University /ID# 262525 โ Atlanta, Georgia
- University of Illinois Hospital and Health Sciences System /ID# 246349 โ Chicago, Illinois
- Rush University Medical Center /ID# 265690 โ Chicago, Illinois
- Nancy W. Knowles Cancer Center /ID# 271361 โ Elmhurst, Illinois
- Springfield Clinic - First /ID# 262266 โ Springfield, Illinois
- Our Lady Of The Lake Regional Medical Center /ID# 272780 โ Baton Rouge, Louisiana
- Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637 โ Bethesda, Maryland
- Beth Israel Deaconess Medical Center /ID# 271535 โ Boston, Massachusetts
- Dana-Farber Cancer Institute /ID# 261554 โ Boston, Massachusetts
- Regents of the University of Michigan /ID# 261577 โ Ann Arbor, Michigan
- Karmanos Cancer Institute - Detroit /ID# 266298 โ Detroit, Michigan
- Henry Ford Hospital /ID# 262704 โ Detroit, Michigan
- Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891 โ Lansing, Michigan
- Mayo Clinic - Rochester /ID# 246228 โ Rochester, Minnesota
- University of Missouri Hospital /ID# 261553 โ Columbia, Missouri
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772 โ Omaha, Nebraska
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple Myeloma
- Ixazomib + Pomalidomide + Dexamethasone In MM โ Boston, Massachusetts
- A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma โ Birmingham, Alabama
- Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant โ Tampa, Florida
- MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb โ Beverly Hills, California
- A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma โ Phoenix, Arizona
- A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma โ Hackensack, New Jersey
Explore by condition: All Multiple Myeloma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.