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New hope for myeloma patients who Can't have transplants

NCT ID NCT07095452

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called etentamig combined with daratumumab in people newly diagnosed with multiple myeloma who are not eligible for a stem cell transplant. About 660 participants will receive either the new combination or standard treatment. The goal is to see if the new combo improves response rates and delays disease progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Etentamig (an investigational drug) combined with daratumumab
What this could lead to
If successful, this could offer a new treatment option for people with newly diagnosed multiple myeloma who cannot have a stem cell transplant, potentially improving disease control and survival.
What could go wrong
This is an early-to-mid-stage trial, so the experimental drug may not work better than current treatments or could cause unexpected side effects. Results may take years to confirm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 660 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2042

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT). * IMWG Myeloma Frailty Index Score of \>= 1 * All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: * Serum M-protein \>= 0.5 g/dL (\>= 5 g/L). * Urine M-protein \>= 200 mg/24 hours. * Serum free light chain (FLC) \>= 100 mg/L (\>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein. Exclusion Criteria: * Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids * Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study * Participant who has known active central nervous system involvement of MM. * Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Blue Ridge Cancer Care - Roanoke /ID# 278722

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • CH Bretagne Atlantique /ID# 278422

    RECRUITING

    Vannes, Morbihan, 56000, France

  • CHRU Tours - Hopital Bretonneau /ID# 279274

    RECRUITING

    Tours, Indre-et-Loire, 37044, France

  • CHU de Montpellier - Hopital Saint Eloi /ID# 278415

    RECRUITING

    Montpellier, Herault, 34295, France

  • Cedars-Sinai Medical Center /ID# 278238

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Annecy Genevois /ID# 278406

    RECRUITING

    Epagny Metz Tessy, Auvergne-Rhône-Alpes, 74370, France

  • Centre Hospitalier De Dunkerque-Hospital Alexandra Lepeve /ID# 278399

    RECRUITING

    Dunkirk, Hauts-de-France, 59385, France

  • Centre Hospitalier Universitaire de Bordeaux /ID# 278419

    RECRUITING

    Pessac, New Aquitaine, 33604, France

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402

    RECRUITING

    Nantes, Pays de la Loire Region, 44000, France

  • Centre Hospitalier Universitaire de Poitiers /ID# 278398

    RECRUITING

    Poitiers, New Aquitaine, 86021, France

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421

    RECRUITING

    St-Priest-en-Jarez, Pays de la Loire Region, 42270, France

  • Chu De Lille - Hopital Claude Huriez /ID# 278413

    RECRUITING

    Lille, Hauts-de-France, 59037, France

  • Clinica Universidad de Navarra - Pamplona /ID# 278583

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Colorado Blood Cancer Institute /ID# 279080

    RECRUITING

    Denver, Colorado, 80218, United States

  • Complejo Asistencial Universitario de Leon - Hospital de Leon /ID# 278534

    RECRUITING

    León, 24071, Spain

  • Complejo Hospitalario Universitario de Santiago /ID# 278531

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Fort Wayne Medical Oncology And Hematology /ID# 278141

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • HCL - Hopital Lyon Sud /ID# 282145

    RECRUITING

    Pierre-Bénite, Rhone, 69495, France

  • Hopital Saint Antoine /ID# 278428

    RECRUITING

    Paris, 75012, France

  • Hopital Saint-Louis /ID# 278429

    RECRUITING

    Paris, 75010, France

  • Hopital Universitaire Necker Enfants Malades /ID# 278426

    RECRUITING

    Paris, Île-de-France Region, 75015, France

  • Hospital Clinic de Barcelona /ID# 278532

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon /ID# 278551

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitari i Politecnic La Fe /ID# 278525

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre /ID# 278520

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Marques de Valdecilla /ID# 278535

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Ramon y Cajal /ID# 278533

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrín /ID# 278527

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

  • Hospital Universitario de Salamanca /ID# 278530

    RECRUITING

    Salamanca, 37007, Spain

  • IUCT Oncopole /ID# 278403

    RECRUITING

    Toulouse, Occitanie, 31059, France

  • Icahn School of Medicine at Mount Sinai /ID# 277844

    RECRUITING

    New York, New York, 10029, United States

  • Institut Catala d'Oncologia (ICO) - Badalona /ID# 278522

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Kurume University Hospital /ID# 278209

    RECRUITING

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Matsuyama Red Cross Hospital /ID# 278660

    RECRUITING

    Matsuyama, Ehime, 790-8524, Japan

  • Mayo Clinic Hospital Rochester /ID# 277886

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital Scottsdale /ID# 278349

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946

    RECRUITING

    New York, New York, 10065, United States

  • Minnesota Oncology - Minneapolis Clinic /ID# 278720

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Nagoya City University Hospital /ID# 278188

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • SCRI Oncology Partners /ID# 278353

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Northeast Texas /ID# 278725

    RECRUITING

    Tyler, Texas, 75702, United States

  • Texas Oncology - The Woodlands /ID# 278726

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Tokai University Hospital /ID# 278157

    RECRUITING

    Isehara, Kanagawa, 259-1193, Japan

  • University Hospital Kyoto Prefectural University of Medicine /ID# 278156

    RECRUITING

    Kyoto, Kyoto, 602-8566, Japan

  • University of North Carolina at Chapel Hill /ID# 277708

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Virginia Cancer Specialists - Fairfax /ID# 278716

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Weill Cornell Medicine Myeloma Center /ID# 278216

    RECRUITING

    New York, New York, 10065, United States

  • Willamette Valley Cancer Institute and Research Center /ID# 278721

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Winship Cancer Institute of Emory University /ID# 277667

    RECRUITING

    Atlanta, Georgia, 30322, United States

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Other studies related to the condition(s) this trial covers.