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A Study to Assess Safety and Efficacy of Surzetoclax Alone or with Etentamig in Adults with Relapsed or Refractory Multiple Myeloma

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study focuses on Multiple Myeloma, a blood cancer that starts in the cells that produce antibodies. It tests an oral tablet called Surzetoclax, which blocks a protein that helps cancer cells survive, and a medicine given through a vein called Etentamig. Both drugs may be used alone or together with other standard treatments that are usually given under the skin or by mouth.

The purpose is to find out how safe the medicines are and whether they can lower the activity of the cancer. Adults whose disease has returned after earlier therapy (relapsed) or does not respond to usual medicines (refractory) will receive the study drugs for several treatment cycles. Participants will have regular doctor visits, blood tests, and scans to watch for side effects and to see if the cancer shrinks. Terms like “biomarker‑selected” mean that a laboratory test is used to choose patients whose cancer has a specific characteristic; “dose limiting toxicity” describes side effects that stop the dose from being increased; and “overall response rate” is the percentage of patients whose cancer gets smaller or disappears.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After you join the study, you will sign an informed consent form that explains the purpose of the trial and what is expected of you.

    The study staff will confirm that you meet the eligibility criteria for participants with relapsed or refractory multiple myeloma.

  2. Step 2

    Baseline assessments

    Before any medication is given, you will undergo a series of tests that may include blood work, imaging, and evaluation of disease activity.

    These assessments provide a reference point to compare later changes during the trial.

  3. Step 3

    Start of oral surzetoclax

    You will begin taking surzetoclax, which is provided as a film‑coated tablet taken by mouth.

    The exact dose, how often you take the tablet, and the length of treatment will be defined by the study protocol and may be adjusted based on safety observations.

  4. Step 4

    Addition of intravenous etentamig (if assigned to combination therapy)

    If you are assigned to the combination arm, you will also receive etentamig, which is given as an intravenous infusion.

    The dose amount, infusion schedule, and duration will follow the study protocol and may be modified according to tolerability.

  5. Step 5

    Regular safety monitoring

    Throughout the treatment period, you will attend scheduled visits where the study team will check for side effects and laboratory changes.

    The primary focus is to identify dose limiting toxicities, which are side effects severe enough to prevent increasing the dose.

  6. Step 6

    Dose‑finding and adjustment phase

    Based on the safety information collected, the study will determine the recommended dose levels for both surzetoclax and etentamig when used together.

    Your dose may be increased, decreased, or kept the same depending on how well you tolerate the medication.

  7. Step 7

    Assessment of treatment effect

    Periodically, the study will evaluate how the disease responds to the therapy using measures such as overall response rate, progression‑free survival, and duration of response.

    These assessments help determine whether the combination is effective.

  8. Step 8

    End of treatment and final evaluation

    Treatment will conclude according to the study schedule or if the disease progresses or unacceptable side effects occur.

    A final set of assessments will be performed to document safety outcomes and any changes in disease activity.

Who can join the trial?

3 criteria

  • Have a confirmed diagnosis of relapsed or refractory Multiple Myeloma (MM), which means the cancer has returned or did not respond to the most recent treatment, and there is documented evidence that it got worse during or after that treatment, as judged by the doctor using the IMWG 2016 criteria (a set of guidelines from the International Myeloma Working Group).
  • Have an ECOG performance status of 0 or 1, indicating you are fully active (0) or able to do light work and up‑and‑down stairs (1) without major limitation.
  • Test positive for the genetic marker t(11;14) or have a high level of the protein BCL2high, as determined by a central laboratory, showing a specific type of the disease the study targets.

Who cannot join the trial?

3 criteria

  • You cannot join if you have already received etentamig or any treatment that is a BCMA bispecific (a type of drug that targets a specific protein on myeloma cells).
  • You cannot join if you had an autologous stem cell transplant (a procedure that uses your own blood‑forming cells) within the past 12 weeks, or an allogeneic stem cell transplant (a procedure that uses donor blood‑forming cells) within the past 6 months. In addition, if you had an allogeneic transplant you must not have any signs of graft‑versus‑host disease (a condition where the donor cells attack your body).
  • You cannot join if, in the last 6 months, you have had a serious problem with any of the following systems that could affect the study: kidney (renal), brain or nerves (neurologic), mental health (psychiatric), hormone (endocrine), body chemistry (metabolic), immune system (immunologic), lungs (pulmonary), or liver (hepatic). The doctor must think the problem could interfere with the trial.
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Investigated drugs

  • Surzetoclax

    is an oral medication that blocks a protein called BCL‑2, which helps cancer cells stay alive. In this study it is being tested to see if it is safe and works well when taken alone or together with other treatments for multiple myeloma. The drug is provided as a film‑coated tablet that patients swallow.

  • Etentamig

    is given by IV infusion and is being evaluated in combination with surzetoclax for people whose multiple myeloma has come back or did not respond to previous therapy. It is administered through a vein as a liquid solution and is intended to work alongside surzetoclax to improve treatment results.

What is already known about the treatment

  • Surzetoclax

    Surzetoclax is taken as a film‑coated tablet that you swallow, delivering the medicine by mouth. It is still an investigational drug and is being studied in clinical trials for people with relapsed or refractory multiple myeloma. The drug works by blocking a protein called BCL‑2, which helps cancer cells survive, thereby allowing the cells to die. It belongs to the class of BCL‑2 inhibitors, a type of targeted oral cancer therapy.

  • Etentamig

    Etentamig is given as a sterile solution that is infused into a vein through an IV line. It is also an investigational agent currently evaluated in trials for multiple myeloma, and it has not yet received market approval. The medicine is designed to attach to cancer cells and trigger the immune system to attack them, helping to reduce tumor growth. It is classified as an experimental intravenous anti‑myeloma therapy.

Investigated diseases

Multiple myeloma - Multiple myeloma is a cancer of plasma cells, a type of white blood cell that produces antibodies. It begins when abnormal plasma cells grow in the bone marrow and crowd out normal blood-forming cells. Over time, the disease can cause the marrow to produce fewer healthy blood cells, leading to anemia, infections, or easy bruising. The abnormal cells also release proteins that can affect kidney function. As the tumor burden increases, bone lesions may develop, causing pain and fractures. The disease typically progresses from an early stage with few symptoms to more extensive involvement of the marrow and bones.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-525105-20-00Protocol codeM25-275 - Substudy 3Estimated enrolment131 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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