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NOT YET RECRUITING
NCT07728188
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Etentamig

Injection

DRUG

Pomalidomide

Oral

DRUG

Daratumumab

Injection

DRUG

Dexamethasone

Oral or Injection

DRUG

Carfilzomib

Injection

DRUG

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