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New hope for Hard-to-Treat myeloma: experimental drug surzetoclax enters human trials

NCT ID NCT06953960

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 8 times

Summary

This study is testing an experimental drug called surzetoclax, alone or combined with other cancer drugs, in about 130 adults with multiple myeloma that has returned or stopped responding to prior treatments. The goal is to find the safest dose and see if it can shrink or control the cancer. Participants will receive the drug as pills or injections and be closely monitored for side effects and disease changes over about 4.5 years.

What this could mean

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

Active substance
surzetoclax (ABBV-453)
What this could lead to
If successful, this could lead to a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or may have unexpected side effects. The study also involves multiple drug combinations, making it harder to isolate the benefit of surzetoclax alone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 325 people

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

Started

Jul 2025

Expected to finish

Dec 2030

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: * Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria. * 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 (\>= 5g/L); OR * Urine M-protein \>= 200 mg/24 hours; OR * For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) \>= 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal. * B-cell lymphoma (BCL)-2 inhibitor treatment naïve. * t(11;14) positive status and/or BCL2 high status. * Must have confirmed diagnosis of relapsed or 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) 2016 criteria. Exclusion Criteria: * Major surgery within 4 weeks of study treatment or planned during study participation. * Recent infection requiring systemic treatment that was completed \<= 14 days before first dose of study treatment and/or uncontrolled active systemic infection.

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Conditions

The condition(s) this trial relates to.

neoplasm 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

    50 sites in 12 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

  • Atrium Health Levine Cancer Institute /ID# 271510

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • CHU de Liege /ID# 271430

    RECRUITING

    Liège, 4000, Belgium

  • CHU de Montpellier - Hopital Saint Eloi /ID# 275570

    RECRUITING

    Montpellier, Herault, 34295, France

  • Calvary Mater Newcastle /ID# 272498

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562

    RECRUITING

    Nantes, Pays de la Loire Region, 44000, France

  • Centre Hospitalier Universitaire de Poitiers /ID# 275563

    RECRUITING

    Poitiers, New Aquitaine, 86021, France

  • Dana-Farber Cancer Institute /ID# 271846

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Epworth HealthCare /ID# 272497

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 276306

    RECRUITING

    Milan, 20122, Italy

  • Hadassah Medical Center-Hebrew University /ID# 271253

    RECRUITING

    Jerusalem, 91120, Israel

  • Hopital Universitaire Necker Enfants Malades /ID# 275571

    RECRUITING

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

  • Huntsman Cancer Institute /ID# 271618

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IUCT Oncopole /ID# 275568

    RECRUITING

    Toulouse, Occitanie, 31059, France

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil /ID# 275873

    RECRUITING

    Lisbon, Lisbon District, 1099-023, Portugal

  • Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 275851

    RECRUITING

    Porto, 4200-072, Portugal

  • Japanese Red Cross Medical Center /ID# 272018

    RECRUITING

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Karolinska University Hospital Solna /ID# 271674

    RECRUITING

    Solna, Stockholm County, 171 64, Sweden

  • Klinikum der Universitaet Muenchen Grosshadern /ID# 276658

    RECRUITING

    Munich, Bavaria, 81337, Germany

  • Liverpool Hospital /ID# 272002

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214

    RECRUITING

    New York, New York, 10065, United States

  • Nagoya City University Hospital /ID# 271427

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 276263

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Northwest Medical Specialties Tacoma /ID# 272506

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Oregon Health and Science University /ID# 272282

    RECRUITING

    Portland, Oregon, 97239, United States

  • Rabin Medical Center. /ID# 272073

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus- Haifa /ID# 271256

    RECRUITING

    Haifa, 3109601, Israel

  • Sahlgrenska Universitetssjukhuset /ID# 272448

    RECRUITING

    Gothenburg, Västra Götaland County, 413 46, Sweden

  • Smilow Cancer Center At Yale-New Haven /ID# 272447

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Sodra Alvsborgs sjukhus /ID# 271822

    RECRUITING

    Borås, Västra Götaland County, 501 82, Sweden

  • St Vincent's Hospital - Melbourne /ID# 271997

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • Tel Aviv Sourasky Medical Center /ID# 271252

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Chaim Sheba Medical Center /ID# 271251

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Christie NHS Foundation Trust - Christie Hospital /ID# 276276

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Jikei University Hospital /ID# 272091

    RECRUITING

    Tokyo, 105-8461, Japan

  • The University of Osaka Hospital /ID# 271636

    RECRUITING

    Suita-shi, Osaka, 565-0871, Japan

  • UZ Gent /ID# 271432

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Unidade Local de Saude de Braga, EPE /ID# 275853

    RECRUITING

    Braga, 4710-243, Portugal

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 275803

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg /ID# 275598

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Wuerzburg /ID# 276657

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitair Ziekenhuis Leuven /ID# 272382

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University Hospital Kyoto Prefectural University of Medicine /ID# 271911

    RECRUITING

    Kyoto, Kyoto, 602-8566, Japan

  • University of Michigan Health System - Ann Arbor /ID# 271536

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill /ID# 272454

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Southern California /ID# 272414

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Texas - Southwestern Medical Center /ID# 271914

    RECRUITING

    Dallas, Texas, 75235, United States

  • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie /ID# 276052

    RECRUITING

    Lublin, Lublin Voivodeship, 20-081, Poland

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276352

    RECRUITING

    Lublin, Lublin Voivodeship, 20-090, Poland

  • Uniwersytecki Szpital Kliniczny W Poznaniu - Przybyszewskiego /ID# 276237

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-355, Poland

  • Wake Forest Baptist Health /ID# 271294

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

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