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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

14 criteria

  • 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
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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.

What is already known about the treatment

ABBV-453 - An investigational BCL-2 inhibitor medication being studied for the treatment of Multiple Myeloma, administered as either monotherapy or in combination with other antimyeloma agents. This drug works at the molecular level by targeting and inhibiting BCL-2 proteins, which play a crucial role in cancer cell survival. Currently undergoing Phase 1/2 clinical trials to evaluate its safety, tolerability, and effectiveness in patients with Multiple Myeloma, ABBV-453 represents a new approach in cancer treatment by specifically targeting cellular mechanisms involved in myeloma cell survival.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517140-65-00Protocol codeM25-275Estimated enrolment119 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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