A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma (NCT07728188)
A Phase 3, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etentamig in Combination With Pomalidomide Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (2L+ RRMM)
๐ฉบ Plain-English Summary (8th-Grade Level)
Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide. Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide. Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: University of Arizona Cancer Center /ID# 285339 โ Tucson, Arizona
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 (66 Sites)
Showing the first 25 of 66 sites.
- University of Arizona Cancer Center /ID# 285339 โ Tucson, Arizona
- Toi Clinical Research - Whittier /ID# 284462 โ Cerritos, California
- University of California Los Angeles /ID# 282444 โ Los Angeles, California
- University Of Colorado - Anschutz Medical Campus /ID# 283478 โ Aurora, Colorado
- MedStar Georgetown University Hospital /ID# 283734 โ Washington D.C., District of Columbia
- Cleveland Clinic Florida /ID# 283692 โ Weston, Florida
- Northwest Georgia Oncology Centers /ID# 284769 โ Marietta, Georgia
- Rush University Medical Center /ID# 283095 โ Chicago, Illinois
- Beth Israel Deaconess Medical Center /ID# 285204 โ Boston, Massachusetts
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591 โ Grand Rapids, Michigan
- The Mount Sinai Hospital /ID# 283535 โ New York, New York
- Columbia University Medical Center /ID# 283510 โ New York, New York
- Weill Cornell Medicine - Cornell University /ID# 283712 โ New York, New York
- University of Rochester Medical Center /ID# 283480 โ Rochester, New York
- University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454 โ Chapel Hill, North Carolina
- Duke University Medical Center /ID# 283475 โ Durham, North Carolina
- Novant Health Forsyth Medical Center /ID# 283485 โ Winston-Salem, North Carolina
- University Hospitals Cleveland Medical Center /ID# 283527 โ Cleveland, Ohio
- Oregon Health and Science University /ID# 282023 โ Portland, Oregon
- SCRI Oncology Partners /ID# 281380 โ Nashville, Tennessee
- MD Anderson Houston /ID# 282622 โ Houston, Texas
- Huntsman Cancer Institute /ID# 283512 โ Salt Lake City, Utah
- VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606 โ Richmond, Virginia
- University of Wisconsin Hospitals and Clinics /ID# 282516 โ Madison, Wisconsin
- Wollongong Hospital. /ID# 282694 โ Wollongong, New South Wales
๐ Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
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 Relapsed or Refractory Multiple Myeloma
- A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2) โ Mobile, Alabama
- A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma โ Anchorage, Alaska
- A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma โ Toronto, Ontario
- A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma โ Duarte, California
- A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma โ Birmingham, Alabama
Explore by condition: All Relapsed or Refractory Multiple Myeloma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.