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 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M22-5382026-525596-11-00
• Study Type: interventional
• Target: 520
• Locations: 13 countries
• Sites: 66

Brief 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.

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

Relapsed or Refractory Multiple Myeloma; Etentamig; Pomalidomide; Cancer

Outcome Measures

Primary Outcomes (3)

• Safety Run-In: Number of Participants With Adverse Events (AE)s

  AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Approximately 75 Months

• Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment

  CR or better is defined as proportion of participants with best overall response (BOR) of CR or stringent CR (sCR) as assessed per International Myeloma Working Group (IMWG) 2016 criteria. CR is defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates. The treatment effect will be summarized as the difference in the CR or better rates between etentamig in combination with pomalidomide and standard available therapies (SAT).

  Up to Approximately 75 Months

• Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment

  PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.

  Up to Approximately 75 Months

Secondary Outcomes (21)

• Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment

  Up to Approximately 75 Months

• Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig

  Up to Approximately 12 Months

• Safety Run-In: Time to Cmax (Tmax) of Etentamig

  Up to Approximately 12 Months

• Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig

  Up to Approximately 12 Months

• Safety Run-In: Immunogenicity of Etentamig

  Up to Approximately 75 Months

Study Arms (3)

Safety Run-In: Etentamig Plus Pomalidomide

EXPERIMENTAL

Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.

Drug: Etentamig; Drug: Pomalidomide

Randomized Portion: Etentamig Plus Pomalidomide

EXPERIMENTAL

Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.

Drug: Etentamig; Drug: Pomalidomide

Randomized Portion: Standard Available Therapy (SAT)

ACTIVE COMPARATOR

Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.

Drug: Daratumumab; Drug: Dexamethasone; Drug: Carfilzomib; Drug: Teclistamab

Interventions

Etentamig DRUG

Injection

Randomized Portion: Etentamig Plus Pomalidomide; Safety Run-In: Etentamig Plus Pomalidomide

Pomalidomide DRUG

Oral

Randomized Portion: Etentamig Plus Pomalidomide; Safety Run-In: Etentamig Plus Pomalidomide

Daratumumab DRUG

Injection

Randomized Portion: Standard Available Therapy (SAT)

Dexamethasone DRUG

Oral or Injection

Randomized Portion: Standard Available Therapy (SAT)

Carfilzomib DRUG

Injection

Randomized Portion: Standard Available Therapy (SAT)

Teclistamab DRUG

Injection

Randomized Portion: Standard Available Therapy (SAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
• Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
• Adequate organ function and performance status

You may not qualify if:

• Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
• Known central nervous system involvement of MM
• Known history of other active malignancies within the past 3 years (with specific exceptions)
• Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)

Sponsors & Collaborators

• AbbVie: lead

Study Sites (66)

University of Arizona Cancer Center /ID# 285339

Tucson, Arizona, 85704, United States

Location

Toi Clinical Research - Whittier /ID# 284462

Cerritos, California, 90703, United States

Location

University of California Los Angeles /ID# 282444

Los Angeles, California, 90095-3075, United States

Location

University Of Colorado - Anschutz Medical Campus /ID# 283478

Aurora, Colorado, 80045, United States

Location

MedStar Georgetown University Hospital /ID# 283734

Washington D.C., District of Columbia, 20007, United States

Location

Cleveland Clinic Florida /ID# 283692

Weston, Florida, 33331, United States

Location

Northwest Georgia Oncology Centers /ID# 284769

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center /ID# 283095

Chicago, Illinois, 60612, United States

Location

Beth Israel Deaconess Medical Center /ID# 285204

Boston, Massachusetts, 02215, United States

Location

Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591

Grand Rapids, Michigan, 49503, United States

Location

The Mount Sinai Hospital /ID# 283535

New York, New York, 10029, United States

Location

Columbia University Medical Center /ID# 283510

New York, New York, 10032, United States

Location

Weill Cornell Medicine - Cornell University /ID# 283712

New York, New York, 10065, United States

Location

University of Rochester Medical Center /ID# 283480

Rochester, New York, 14642, United States

Location

University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center /ID# 283475

Durham, North Carolina, 27710, United States

Location

Novant Health Forsyth Medical Center /ID# 283485

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Cleveland Medical Center /ID# 283527

Cleveland, Ohio, 44106, United States

Location

Oregon Health and Science University /ID# 282023

Portland, Oregon, 97239, United States

Location

SCRI Oncology Partners /ID# 281380

Nashville, Tennessee, 37203, United States

Location

MD Anderson Houston /ID# 282622

Houston, Texas, 77030-4000, United States

Location

Huntsman Cancer Institute /ID# 283512

Salt Lake City, Utah, 84112, United States

Location

VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606

Richmond, Virginia, 23298, United States

Location

University of Wisconsin Hospitals and Clinics /ID# 282516

Madison, Wisconsin, 53792, United States

Location

Wollongong Hospital. /ID# 282694

Wollongong, New South Wales, 2500, Australia

Location

Pindara Private Hospital /ID# 283010

Benowa, Queensland, 4217, Australia

Location

Icon Cancer Care - South Brisbane /ID# 282965

South Brisbane, Queensland, 4101, Australia

Location

Peter MacCallum Cancer Centre. /ID# 282692

Melbourne, Victoria, 3000, Australia

Location

Epworth Hospital - Richmond /ID# 281877

Richmond, Victoria, 3121, Australia

Location

Fiona Stanley Hospital /ID# 281879

Murdoch, Western Australia, 6150, Australia

Location

Sir Charles Gairdner Hospital /ID# 281881

Nedlands, Western Australia, 6009, Australia

Location

British Columbia Cancer Agency Vancouver Centre /ID# 282147

Victoria, British Columbia, V8R 6V5, Canada

Location

London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149

London, Ontario, N6A 5W9, Canada

Location

Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705

Montreal, Quebec, H1T 2M4, Canada

Location

Chu de Nice-Hopital Larchet Ii /Id# 283541

Nice, Alpes-Maritimes, 06202, France

Location

CHRU Tours - Hopital Bretonneau /ID# 281925

Tours, Indre-et-Loire, 37044, France

Location

Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025

Nantes, Pays de la Loire Region, 44000, France

Location

Centre Hospitalier d'Avignon /ID# 283509

Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France

Location

Universitaetsklinikum Freiburg /ID# 282874

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Staedtisches Klinikum Karlsruhe /ID# 283569

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Universitaetsklinikum Tuebingen /ID# 282873

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Ulm /ID# 283884

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Universitaetsklinikum Wuerzburg /ID# 283572

Würzburg, Bavaria, 97080, Germany

Location

Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729

Hanover, Lower Saxony, 30459, Germany

Location

Universitaetsklinikum Bonn /ID# 283881

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitaetsklinikum Koeln /ID# 283930

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136

Szombathely, Vas County, 9700, Hungary

Location

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398

Meldola, Forlì-Cesena, 47014, Italy

Location

Leids Universitair Medisch Centrum /ID# 283142

Leiden, South Holland, 2333 ZA, Netherlands

Location

Erasmus Medisch Centrum /ID# 283408

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Haukeland University Hospital /ID# 283524

Bergen, Sogn Og Fjordane, 5021, Norway

Location

Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500

Lisbon, Lisbon District, 1449-005, Portugal

Location

Unidade Local de Saude de Gaia/Espinho /ID# 283492

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

2CA-Braga, Hospital de Braga /ID# 283828

Braga, 4710-243, Portugal

Location

Unidade Local de Saude Sao Joao /ID# 283530

Porto, 4200-319, Portugal

Location

Hospital Universitario Marques de Valdecilla /ID# 283344

Santander, Cantabria, 39008, Spain

Location

Clinica Universidad de Navarra - Pamplona /ID# 283290

Pamplona, Navarre, 31008, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 283342

Madrid, 28007, Spain

Location

Kaohsiung Chang Gung Memorial Hospital /ID# 282970

Kaohsiung City, 833, Taiwan

Location

University Hospitals Plymouth NHS Trust /ID# 283108

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Western General Hospital - NHS Lothian /ID# 281838

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

Location

St Bartholomews Hospital - Barts Health /ID# 283714

London, Greater London, EC1A 7BE, United Kingdom

Location

Queen Alexandra Hospital /ID# 281839

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

NHS Lanarkshire /ID# 282021

Airdrie, North Lanarkshire, ML6 0JS, United Kingdom

Location

Nottingham City Hospital /ID# 282748

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma; Neoplasms

Interventions

pomalidomide; daratumumab; Dexamethasone; carfilzomib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CA (3); FR (5); NO (1); TW (1); US (24); DE (8); NL (2); PT (4); IT (1); GB (6); HU (1); ES (3); AU (7)