Study of ABBV-453 alone or with drug combination for adults with multiple myeloma: evaluation of safety and effectiveness

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What is this study about?

This study focuses on patients with Multiple Myeloma, a type of blood cancer that develops in plasma cells found in bone marrow. The research evaluates a new medication called ABBV-453 (also known as Surzetoclax), which will be tested either alone or in combination with other medications including Daratumumab, Pomalidomide, and Dexamethasone.

The main purpose is to understand how safe the new medication ABBV-453 is and how well patients tolerate it when used alone or combined with other multiple myeloma treatments. ABBV-453 belongs to a group of drugs called BCL-2 inhibitors, which work by blocking a protein that helps cancer cells survive.

During the study, patients will receive ABBV-453 tablets by mouth, either by itself or together with other medications that may be given as tablets or as injections under the skin. The study will monitor how patients respond to treatment and track any side effects that may occur. Doctors will regularly check patients’ blood and perform other medical tests to evaluate how well the treatment is working.

1 Initial medical evaluation

A medical assessment will confirm your multiple myeloma (MM) diagnosis according to international standards

Laboratory tests will measure your disease levels through blood and urine samples

The tests must show at least one of these results:

– Blood protein level of 0.5 g/dL or higher

– Urine protein level of 200 mg or more in 24 hours

– Special blood protein test showing levels of 10 mg/dL or higher

2 Treatment administration

You will receive a combination of medications:

Daratumumab – given as an injection under the skin

Surzetoclax – taken by mouth as a film-coated tablet

Pomalidomide – taken by mouth

Dexamethasone – taken by mouth

3 Regular monitoring

Your health will be monitored through:

Regular blood tests

Physical examinations

Heart activity measurements (ECG)

Vital signs checks

Assessment of any side effects

4 Disease response evaluation

Your response to treatment will be measured by:

Checking if the disease is getting better or worse

Measuring the amount of disease in your body

Monitoring how long the treatment keeps working

Testing for any remaining cancer cells

5 Long-term follow-up

The study will continue until May 2029

Your overall health and survival will be monitored

Any need for additional treatments will be tracked

Regular assessments will continue throughout the study period

Who Can Join the Study?

Must have a confirmed diagnosis of multiple myeloma according to international medical standards
Must have measurable disease levels that meet at least one of these criteria when tested within 28 days before joining:
- Serum M-protein (a type of protein found in blood) level of 0.5 g/dL or higher
- Urine M-protein (protein found in urine) of 200 mg or more in a 24-hour collection
- If M-proteins are not measurable in blood or urine: serum free light chains (another type of protein) must be 10 mg/dL or higher with abnormal ratio
Must never have received treatment with medicines known as BCL-2 inhibitors (a specific type of cancer treatment)
Must be an adult (18 years or older)
Can be either male or female

Who Cannot Join the Study?

Age below 18 years old or above 65 years old
Pregnant or breastfeeding women
History of severe allergic reactions to medications
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Significant heart problems or uncontrolled high blood pressure
Severe kidney or liver dysfunction
Other types of cancer within the past 3 years (except for successfully treated non-melanoma skin cancer)
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within 30 days before this study
Mental conditions that could interfere with following study procedures
Uncontrolled diabetes
Regular use of medications that could interact with the study drug
History of stroke or brain hemorrhage within the past 6 months
Serious lung conditions or breathing problems

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Karolinska University Hospital	Solna	Sweden
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Hopital Beaujon	Clichy	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Ujhnjtnqgy Mzkgysh Cywfcf Hnaejjujxchwhufbq	Hamburg	Germany
Ihalmqak Rlrrpkjlc Prt Lj Ssooru Dwy Tfsort Dgdy Akwctou Imtc Swfnof	Meldola	Italy
Aoaofef Obecijttsve Uhgxvgdcgjguy Ckuuptcwoiek Dqcnz Sldvgk E Drvyp Shcfwzg Di Timgyw	Turin	Italy
Nxpfhrci Inuwpokt Omzygsnil Ihs Mbihx Swgcddxfweitapdjwaqxjtahqyvk Ietmavdl Bdmeondh	Cracow	Poland
Kbdliocz dzt Uyxqhvkjwfmr Mnvpciyu Avf	Munich	Germany
Uybqayixvkyjzxlqashbu Wbswscldf Aiz	Wuerzburg	Germany
Adhbiof Obnktbrdoqf Pnhe Gtitkntd Xgnbx	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.12.2025
France	Recruiting	15.12.2025
Germany	Recruiting	15.12.2025
Italy	Recruiting	15.12.2025
Poland	Recruiting	15.12.2025
Portugal	Recruiting	15.12.2025
Sweden	Recruiting	15.12.2025

Trial locations

Investigated drugs:

ABBV-453 is a BCL-2 inhibitor medication being studied for treating multiple myeloma. BCL-2 inhibitors work by blocking a protein that helps cancer cells survive. This medication is being tested both alone and in combination with other medications that treat multiple myeloma.

The trial also includes unnamed antimyeloma agents, which are standard medications used to treat multiple myeloma. These are existing treatments that will be combined with ABBV-453 to study if they work better together.

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, abnormal plasma cells multiply rapidly in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells produce large amounts of abnormal proteins while crowding out healthy blood cells. The disease typically affects multiple bones and can weaken them over time. Multiple myeloma often develops gradually and may initially not cause any symptoms.

Trial ID:

2024-517140-65-00

Protocol code:

M25-275

NCT ID:

NCT06953960

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of ABBV-453 alone or with drug combination for adults with multiple myeloma: evaluation of safety and effectiveness

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?