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Relapsed or Refractory Multiple MyelomaPhase 3NCT07728188

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

A Phase 3 study testing Etentamig, Pomalidomide and Daratumumab in people with Relapsed or Refractory Multiple Myeloma, run by AbbVie at 66 sites in 13 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
Etentamig, Pomalidomide and Daratumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
66 sitesin 13 countries
Study dates
30 Nov 2026to Feb 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

66 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

66 sites in 13 countries

United States24 sites

  • University Of Colorado - Anschutz Medical Campus /ID# 283478

    Aurora, Colorado, 80045

  • Beth Israel Deaconess Medical Center /ID# 285204

    Boston, Massachusetts, 02215

  • Toi Clinical Research - Whittier /ID# 284462

    Cerritos, California, 90703

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

    Chapel Hill, North Carolina, 27599

  • Rush University Medical Center /ID# 283095

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center /ID# 283527

    Cleveland, Ohio, 44106

  • Duke University Medical Center /ID# 283475

    Durham, North Carolina, 27710

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

    Grand Rapids, Michigan, 49503

  • MD Anderson Houston /ID# 282622

    Houston, Texas, 77030-4000

  • University of California Los Angeles /ID# 282444

    Los Angeles, California, 90095-3075

  • University of Wisconsin Hospitals and Clinics /ID# 282516

    Madison, Wisconsin, 53792

  • Northwest Georgia Oncology Centers /ID# 284769

    Marietta, Georgia, 30060

  • SCRI Oncology Partners /ID# 281380

    Nashville, Tennessee, 37203

  • The Mount Sinai Hospital /ID# 283535

    New York, New York, 10029

  • Columbia University Medical Center /ID# 283510

    New York, New York, 10032

  • Weill Cornell Medicine - Cornell University /ID# 283712

    New York, New York, 10065

  • Oregon Health and Science University /ID# 282023

    Portland, Oregon, 97239

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

    Richmond, Virginia, 23298

  • University of Rochester Medical Center /ID# 283480

    Rochester, New York, 14642

  • Huntsman Cancer Institute /ID# 283512

    Salt Lake City, Utah, 84112

  • University of Arizona Cancer Center /ID# 285339

    Tucson, Arizona, 85704

  • MedStar Georgetown University Hospital /ID# 283734

    Washington D.C., District of Columbia, 20007

  • Cleveland Clinic Florida /ID# 283692

    Weston, Florida, 33331

  • Novant Health Forsyth Medical Center /ID# 283485

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany8 sites

  • Universitaetsklinikum Bonn /ID# 283881

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Koeln /ID# 283930

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Freiburg /ID# 282874

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729

    Hanover, Lower Saxony, 30459

  • Staedtisches Klinikum Karlsruhe /ID# 283569

    Karlsruhe, Baden-Wurttemberg, 76133

  • Universitaetsklinikum Tuebingen /ID# 282873

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm /ID# 283884

    Ulm, Baden-Wurttemberg, 89081

  • Universitaetsklinikum Wuerzburg /ID# 283572

    Würzburg, Bavaria, 97080

Other trials in Germany

Australia7 sites

  • Pindara Private Hospital /ID# 283010

    Benowa, Queensland, 4217

  • Peter MacCallum Cancer Centre. /ID# 282692

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital /ID# 281879

    Murdoch, Western Australia, 6150

  • Sir Charles Gairdner Hospital /ID# 281881

    Nedlands, Western Australia, 6009

  • Epworth Hospital - Richmond /ID# 281877

    Richmond, Victoria, 3121

  • Icon Cancer Care - South Brisbane /ID# 282965

    South Brisbane, Queensland, 4101

  • Wollongong Hospital. /ID# 282694

    Wollongong, New South Wales, 2500

Other trials in Australia

United Kingdom6 sites

  • NHS Lanarkshire /ID# 282021

    Airdrie, North Lanarkshire, ML6 0JS

  • Western General Hospital - NHS Lothian /ID# 281838

    Edinburgh, Edinburgh, City of, EH4 2XU

  • St Bartholomews Hospital - Barts Health /ID# 283714

    London, Greater London, EC1A 7BE

  • Nottingham City Hospital /ID# 282748

    Nottingham, Nottinghamshire, NG5 1PB

  • University Hospitals Plymouth NHS Trust /ID# 283108

    Plymouth, Devon, PL6 8DH

  • Queen Alexandra Hospital /ID# 281839

    Portsmouth, Hampshire, PO6 3LY

Other trials in United Kingdom

France5 sites

  • Centre Hospitalier d'Avignon /ID# 283509

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

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

    Nantes, Pays de la Loire Region, 44000

  • Chu de Nice-Hopital Larchet Ii /Id# 283541

    Nice, Alpes-Maritimes, 06202

  • CHRU Tours - Hopital Bretonneau /ID# 281925

    Tours, Indre-et-Loire, 37044

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

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

Other trials in France

Portugal4 sites

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

    Braga, 4710-243

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

    Lisbon, Lisbon District, 1449-005

  • Unidade Local de Saude Sao Joao /ID# 283530

    Porto, 4200-319

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

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Canada3 sites

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

    London, Ontario, N6A 5W9

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

    Montreal, Quebec, H1T 2M4

  • British Columbia Cancer Agency Vancouver Centre /ID# 282147

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Spain3 sites

  • Hospital General Universitario Gregorio Maranon /ID# 283342

    Madrid, 28007

  • Clinica Universidad de Navarra - Pamplona /ID# 283290

    Pamplona, Navarre, 31008

  • Hospital Universitario Marques de Valdecilla /ID# 283344

    Santander, Cantabria, 39008

Other trials in Spain

Netherlands2 sites

  • Leids Universitair Medisch Centrum /ID# 283142

    Leiden, South Holland, 2333 ZA

  • Erasmus Medisch Centrum /ID# 283408

    Rotterdam, South Holland, 3015 CE

Other trials in Netherlands

Hungary1 site

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136

    Szombathely, Vas County, 9700

Other trials in Hungary

Italy1 site

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

    Meldola, Forlì-Cesena, 47014

Other trials in Italy

Norway1 site

  • Haukeland University Hospital /ID# 283524

    Bergen, Sogn Og Fjordane, 5021

Other trials in Norway

Taiwan1 site

  • Kaohsiung Chang Gung Memorial Hospital /ID# 282970

    Kaohsiung City, 833

Other trials in Taiwan

About this study

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)

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.

Read more

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.

Keywords
Relapsed or Refractory Multiple Myeloma, Etentamig, Pomalidomide, Cancer
Medical subject headings
Recurrence, Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07728188
Study groupRoleWhat they receive
Safety Run-In: Etentamig Plus PomalidomideExperimentalParticipants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Receives: Drug: Etentamig; Drug: Pomalidomide
Randomized Portion: Etentamig Plus PomalidomideExperimentalParticipants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Receives: Drug: Etentamig; Drug: Pomalidomide
Randomized Portion: Standard Available Therapy (SAT)Active comparatorParticipants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.
Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Carfilzomib; Drug: Teclistamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Approximately 75 Months

  2. 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).

    Measured: Up to Approximately 75 Months

  3. 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.

    Measured: Up to Approximately 75 Months

Secondary outcomes (21)

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

    BOR is defined as the best response achieved across all response assessments, partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR), from randomization until disease progression per investigator assessment, using IMWG (2016) response criteria.

    Measured: Up to Approximately 75 Months

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

    Cmax of Etentamig.

    Measured: Up to Approximately 12 Months

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

    Cmax of Etentamig.

    Measured: Up to Approximately 12 Months

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

    Cmax of Etentamig.

    Measured: Up to Approximately 12 Months

  5. Safety Run-In: Immunogenicity of Etentamig

    Immunogenicity of etentamig is defined as the summary of antidrug antibody (ADA) status, ADA titers, and neutralizing antibody (NAb)s, if NAb samples are analyzed.

    Measured: Up to Approximately 75 Months

  6. Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment

    MRDnegCR is defined as achievement of CR or better by IMWG (2016) response criteria per IRC assessment and MRD negative status as assessed by next-generation sequencing (NGS) at threshold defined in the protocol.

    Measured: Up to Approximately 75 Months

  7. Randomized Portion: Overall Survival (OS)

    Overall Survival (OS) is defined as the duration from the date of randomization to the date of death from any cause.

    Measured: Up to Approximately 75 Months

  8. Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity

    Sustained MRD negativity assessed in participants with relapsed/refractory multiple myeloma (RRMM).

    Measured: Up to Approximately 75 Months

  9. Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment

    Best MRD negative CR per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).

    Measured: Up to Approximately 75 Months

  10. Randomized Portion: BOR Per IRC Assessment

    BOR is defined as the best response achieved across all response assessments, PR + VGPR + CR +sCR from randomization until disease progression per IRC assessment, using IMWG (2016) response criteria.

    Measured: Up to Approximately 75 Months

  11. Randomized Portion: VGPR or Better Rate Per IRC Assessment

    VGPR or better rate per IRC assessment, defined as percentage of participants achieving VGPR, CR, or sCR using IMWG (2016) response criteria.

    Measured: Up to Approximately 75 Months

  12. Randomized Portion: Time to Response (TTR) Per IRC Assessment

    TTR is defined as the time from randomization to first documented response (PR or better) per IRC assessment using IMWG (2016) response criteria.

    Measured: Up to Approximately 75 Months

  13. Randomized Portion: Duration of Response (DOR) Per IRC Assessment

    DOR is defined as the time from first documented response (PR or better) to disease progression or death, whichever occurs first, per IRC assessment using IMWG (2016) response criteria.

    Measured: Up to Approximately 75 Months

  14. Randomized Portion: Second Progression-Free Survival (PFS2)

    PFS2 is defined as time from randomization to second disease progression or death from any cause, whichever occurs first.

    Measured: Up to Approximately 75 Months

  15. Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (QoL) Score

    Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life score. Patient-reported outcome (PRO) assessment.

    Measured: Up to Approximately 75 Months

  16. Randomized Portion: Event-Free Survival (EFS) Per IRC Assessment

    EFS per IRC assessment in participants with relapsed/refractory multiple myeloma (RRMM).

    Measured: Up to Approximately 75 Months

  17. Randomized Portion: Time to Next Treatment (TTNT)

    TTNT is defined as time from randomization to initiation of next anti-myeloma therapy.

    Measured: Up to Approximately 75 Months

  18. Randomized Portion: Time to Symptomatic Disease Progression

    Time to symptomatic disease progression in participants with relapsed/refractory multiple myeloma (RRMM).

    Measured: Up to Approximately 75 Months

  19. Randomized Portion: Change From Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma Module (EORTC QLQ-MY20)

    Change from baseline in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20 .

    Measured: Up to Approximately 75 Months

  20. Randomized Portion: Change From Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30.

    Measured: Up to Approximately 75 Months

  21. Randomized Portion: Overall Bother Due to Treatment Side Effects as Assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 (FACT-G GP5)

    Overall bother due to treatment side effects as assessed by the Functional Assessment of Cancer Therapy - General Population, Item 5 FACT-G GP5. Patient-reported outcome (PRO) assessment.

    Measured: Up to Approximately 75 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completionFeb 2033 (estimated)
  4. Study completionFeb 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07728188
Sponsor's protocol ID
M22-538
Other IDs
2026-525596-11-00
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etentamig, Pomalidomide and Daratumumab in people with Relapsed or Refractory Multiple Myeloma, run by AbbVie at 66 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Germany, Australia, United Kingdom, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Run-In: Number of Participants With Adverse Events (AE)s (time frame: Up to Approximately 75 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07728188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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