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New combo therapy targets Hard-to-Treat myeloma

NCT ID NCT05259839

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 1 time

Summary

This early-stage study tests a new drug called etentamig combined with standard treatments for people with multiple myeloma that has come back or stopped responding to therapy. About 320 adults will take part to find the safest dose and check for side effects. The goal is to control the disease, not cure it.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

283 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Sep 2033

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: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria. * Must have measurable disease as determined by central lab as outlined in the protocol. * Must be naïve to treatment with Etentamig. * Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded. * Arms A, B and C: Participant has received at least 3 prior lines of MM treatment. * Arm E: Participant has received 1-3 prior lines of MM treatment. Exclusion Criteria: * Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment. * Unresolved adverse event (AE)s \>= Grade 2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from prior anticancer therapy. * Has any of the following conditions: * Nonsecretory Multiple Myeloma (MM). * Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or \> 2.0 × 10\^9L circulating plasma cells by standard differential. * Waldenstrom's macroglobulinemia. * Light chain amyloidosis. * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome. * Major surgery within 4 weeks prior to first dose or planned study participation. * Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral). * Uncontrolled diabetes or hypertension within 14 days prior to first dose. * Peripheral neuropathy \>= Grade 3 or \>= Grade 2 with pain within 2 weeks prior to first dose.

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Conditions

The condition(s) this trial relates to.

neoplasm plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

Relapsed/refractory multiple myeloma

Contacts and locations

Locations

  • Atrium Health Levine Cancer Institute /ID# 242851

    Charlotte, North Carolina, 28204, United States

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145

    Madrid, 28027, Spain

  • Calvary Mater Newcastle /ID# 243730

    Waratah, New South Wales, 2298, Australia

  • Clinica Universidad de Navarra - Pamplona /ID# 242977

    Pamplona, Navarre, 31008, Spain

  • Dana-Farber Cancer Institute /ID# 249529

    Boston, Massachusetts, 02215, United States

  • Epworth Healthcare /ID# 243734

    Richmond, Victoria, 3121, Australia

  • Fiona Stanley Hospital /ID# 244753

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 242582

    Rome, Roma, 00168, Italy

  • Froedtert Memorial Lutheran Hospital /ID# 242654

    Milwaukee, Wisconsin, 53226-3522, United States

  • Hokkaido University Hospital /ID# 245966

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital Clinic de Barcelona /ID# 242978

    Barcelona, 08036, Spain

  • Hospital Duran i Reynals /ID# 242979

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario 12 de Octubre /ID# 242975

    Madrid, 28041, Spain

  • Hospital Universitario Vall de Hebron /ID# 242976

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio /ID# 242974

    Seville, 41013, Spain

  • Huntsman Cancer Institute /ID# 242872

    Salt Lake City, Utah, 84112-5500, United States

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 242581

    Bologna, 40138, Italy

  • IRCCS Ospedale San Raffaele /ID# 242583

    Milan, Milano, 20132, Italy

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584

    Meldola, Forlì-Cesena, 47014, Italy

  • Kanazawa University Hospital /ID# 246812

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Memorial Sloan Kettering Cancer Center /ID# 244656

    New York, New York, 10065-6007, United States

  • Moffitt Cancer Center /ID# 243437

    Tampa, Florida, 33612-9416, United States

  • Monash Health - Monash Medical Centre - Clayton /ID# 244403

    Clayton, Victoria, 3168, Australia

  • Nagoya City University Hospital /ID# 249094

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital East /ID# 245889

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Okayama Medical Center /ID# 245882

    Okayama, Okayama-ken, 701-1192, Japan

  • Peter MacCallum Cancer Ctr /ID# 256880

    Melbourne, Victoria, 3000, Australia

  • Rutenberg Cancer Center /ID# 244647

    New York, New York, 10029-6030, United States

  • St George Hospital - Kogarah /ID# 243740

    Kogarah, New South Wales, 2217, Australia

  • St Vincent's Hospital Melbourne /ID# 256879

    Fitzroy Melbourne, Victoria, 3065, Australia

  • Sylvester Comprehensive Cancer Center /ID# 243673

    Miami, Florida, 33136-1002, United States

  • Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954

    Opole, Lower Silesian Voivodeship, 45-372, Poland

  • The Valley Hospital /ID# 243829

    Paramus, New Jersey, 07652, United States

  • Universitaetsklinikum Essen /ID# 242819

    Essen, 45147, Germany

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 243141

    Hamburg, 20246, Germany

  • Universitaetsklinikum Regensburg /ID# 242837

    Regensburg, Bavaria, 93042, Germany

  • Universitaetsklinikum Tuebingen /ID# 242815

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Wuerzburg /ID# 242826

    Würzburg, Bavaria, 97080, Germany

  • University of Arkansas for Medical Sciences /ID# 243096

    Little Rock, Arkansas, 72205, United States

  • University of Maryland, Baltimore /ID# 243679

    Baltimore, Maryland, 21201, United States

  • University of Massachusetts - Worcester /ID# 243977

    Worcester, Massachusetts, 01655, United States

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438

    Ann Arbor, Michigan, 48109, United States

  • University of Texas - Southwestern Medical Center /ID# 243273

    Dallas, Texas, 75235, United States

  • University of Washington /ID# 243172

    Seattle, Washington, 98109, United States

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500

    Lublin, Lublin Voivodeship, 20-081, Poland

  • Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 243246

    Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

  • Uniwersyteckie Centrum Kliniczne /ID# 243249

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Yamagata University Hospital /ID# 245888

    Yamagata, Yamagata, 990-9585, Japan

More trials for these conditions

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