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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
Sponsor: AbbVie
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
520
Start Date
2026-11-30
Completion Date
2033-02
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Etentamig
Injection
Pomalidomide
Oral
Daratumumab
Injection
Dexamethasone
Oral or Injection
Carfilzomib
Injection
Teclistamab
Injection
Locations (66)
University of Arizona Cancer Center /ID# 285339
Tucson, Arizona, United States
Toi Clinical Research - Whittier /ID# 284462
Cerritos, California, United States
University of California Los Angeles /ID# 282444
Los Angeles, California, United States
University Of Colorado - Anschutz Medical Campus /ID# 283478
Aurora, Colorado, United States
MedStar Georgetown University Hospital /ID# 283734
Washington D.C., District of Columbia, United States
Cleveland Clinic Florida /ID# 283692
Weston, Florida, United States
Northwest Georgia Oncology Centers /ID# 284769
Marietta, Georgia, United States
Rush University Medical Center /ID# 283095
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center /ID# 285204
Boston, Massachusetts, United States
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591
Grand Rapids, Michigan, United States
The Mount Sinai Hospital /ID# 283535
New York, New York, United States
Columbia University Medical Center /ID# 283510
New York, New York, United States
Weill Cornell Medicine - Cornell University /ID# 283712
New York, New York, United States
University of Rochester Medical Center /ID# 283480
Rochester, New York, United States
University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454
Chapel Hill, North Carolina, United States
Duke University Medical Center /ID# 283475
Durham, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 283485
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center /ID# 283527
Cleveland, Ohio, United States
Oregon Health and Science University /ID# 282023
Portland, Oregon, United States
SCRI Oncology Partners /ID# 281380
Nashville, Tennessee, United States
MD Anderson Houston /ID# 282622
Houston, Texas, United States
Huntsman Cancer Institute /ID# 283512
Salt Lake City, Utah, United States
VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606
Richmond, Virginia, United States
University of Wisconsin Hospitals and Clinics /ID# 282516
Madison, Wisconsin, United States
Wollongong Hospital. /ID# 282694
Wollongong, New South Wales, Australia
Pindara Private Hospital /ID# 283010
Benowa, Queensland, Australia
Icon Cancer Care - South Brisbane /ID# 282965
South Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre. /ID# 282692
Melbourne, Victoria, Australia
Epworth Hospital - Richmond /ID# 281877
Richmond, Victoria, Australia
Fiona Stanley Hospital /ID# 281879
Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital /ID# 281881
Nedlands, Western Australia, Australia
British Columbia Cancer Agency Vancouver Centre /ID# 282147
Victoria, British Columbia, Canada
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149
London, Ontario, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705
Montreal, Quebec, Canada
Chu de Nice-Hopital Larchet Ii /Id# 283541
Nice, Alpes-Maritimes, France
CHRU Tours - Hopital Bretonneau /ID# 281925
Tours, Indre-et-Loire, France
Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025
Nantes, Pays de la Loire Region, France
Centre Hospitalier d'Avignon /ID# 283509
Avignon, Provence-Alpes-Côte d'Azur Region, France
Universitaetsklinikum Freiburg /ID# 282874
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Staedtisches Klinikum Karlsruhe /ID# 283569
Karlsruhe, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen /ID# 282873
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 283884
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 283572
Würzburg, Bavaria, Germany
Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729
Hanover, Lower Saxony, Germany
Universitaetsklinikum Bonn /ID# 283881
Bonn, North Rhine-Westphalia, Germany
Universitaetsklinikum Koeln /ID# 283930
Cologne, North Rhine-Westphalia, Germany
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136
Szombathely, Vas County, Hungary
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398
Meldola, Forlì-Cesena, Italy
Leids Universitair Medisch Centrum /ID# 283142
Leiden, South Holland, Netherlands
Erasmus Medisch Centrum /ID# 283408
Rotterdam, South Holland, Netherlands
Haukeland University Hospital /ID# 283524
Bergen, Sogn Og Fjordane, Norway
Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Gaia/Espinho /ID# 283492
Vila Nova de Gaia, Porto District, Portugal
2CA-Braga, Hospital de Braga /ID# 283828
Braga, Portugal
Unidade Local de Saude Sao Joao /ID# 283530
Porto, Portugal
Hospital Universitario Marques de Valdecilla /ID# 283344
Santander, Cantabria, Spain
Clinica Universidad de Navarra - Pamplona /ID# 283290
Pamplona, Navarre, Spain
Hospital General Universitario Gregorio Maranon /ID# 283342
Madrid, Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 282970
Kaohsiung City, Taiwan
University Hospitals Plymouth NHS Trust /ID# 283108
Plymouth, Devon, United Kingdom
Western General Hospital - NHS Lothian /ID# 281838
Edinburgh, Edinburgh, City of, United Kingdom
St Bartholomews Hospital - Barts Health /ID# 283714
London, Greater London, United Kingdom
Queen Alexandra Hospital /ID# 281839
Portsmouth, Hampshire, United Kingdom
NHS Lanarkshire /ID# 282021
Airdrie, North Lanarkshire, United Kingdom
Nottingham City Hospital /ID# 282748
Nottingham, Nottinghamshire, United Kingdom