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Study of Venetoclax, Daratumumab, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a condition called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is exploring the effectiveness of a combination of treatments for patients whose disease has returned or has not responded to previous treatments. The treatments being tested include Venetoclax (also known by its code name ABT-199), Daratumumab (marketed as Darzalex), Dexamethasone, and Bortezomib (marketed as Velcade). These medications are used in different combinations to see how well they work together in treating this condition.

The purpose of the study is to evaluate how these combinations of medications can help patients with relapsed or refractory multiple myeloma, particularly those with a specific genetic feature known as t(11;14) positive. The study will involve giving these medications to participants through different methods, such as intravenous (IV) infusion, subcutaneous injection, or oral tablets, depending on the medication. Some participants may receive a placebo as part of the study. The trial will monitor how the disease responds to these treatments over time, including how long it takes for the treatment to start working and how long the effects last.

Participants in the study will receive regular check-ups and monitoring to assess their response to the treatment and to ensure their safety. The study aims to gather information on the overall response rate, the time it takes for the disease to progress, and the overall survival of participants. This information will help researchers understand the potential benefits and risks of these treatment combinations for people with multiple myeloma.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Blood tests and other diagnostic procedures are performed to ensure the participant meets the study criteria.

  2. Step 2

    Treatment phase 1

    Participants receive a combination of medications: venetoclax, daratumumab, and dexamethasone. This combination is referred to as VenDd.

    Daratumumab is administered as an intravenous infusion. The frequency and dosage are determined by the study protocol.

    Venetoclax is taken orally in the form of film-coated tablets. The dosage is adjusted based on individual response and tolerance.

    Dexamethasone is administered as part of the treatment regimen to manage inflammation and other symptoms.

  3. Step 3

    Treatment phase 2

    For some participants, the treatment includes an additional medication, bortezomib, along with venetoclax, daratumumab, and dexamethasone. This combination is referred to as VenDVd.

    Bortezomib is administered either as an intravenous infusion or a subcutaneous injection, depending on the participant's condition and response.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, regular monitoring is conducted to assess the participant's response to the treatment.

    This includes blood tests, imaging studies, and other evaluations to measure the effectiveness of the therapy and monitor for any side effects.

  5. Step 5

    Follow-up

    After completing the treatment phases, participants undergo a follow-up period to evaluate long-term outcomes.

    The follow-up includes periodic health assessments and monitoring of disease progression or remission.

Who can join the trial?

9 criteria

  • The participant must have a performance status of 2 or less on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a person can perform daily activities.
  • The participant must have relapsed or refractory multiple myeloma, meaning the disease has returned or is not responding to treatment, with proof of worsening condition during or after the last treatment.
  • The participant must have a measurable disease confirmed by a central lab at the start of the study. This can be shown by one of the following:
    • Serum M-protein level of 1.0 g/dL or higher.
    • Urine M-protein level of 200 mg/24 hours or higher.
    • Serum free light chain (FLC) level of 10 mg/dL or higher, with an abnormal FLC ratio, for those without measurable disease by other tests.
    • The participant must have received previous treatment for multiple myeloma as specified in the study protocol.
    • Bone marrow samples must have been collected from the participant.
    • For certain parts of the study, the participant must be t(11;14) positive, which is a specific genetic marker, as determined by a special lab test called Fluorescent In Situ Hybridization (FISH).
    • The participant must have adequate blood, kidney, and liver function.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who have not received at least one previous treatment for Multiple Myeloma that included a proteasome inhibitor and an immunomodulatory agent cannot participate. A proteasome inhibitor is a drug that blocks the action of proteasomes, which are parts of cells that break down proteins. An immunomodulatory agent is a drug that helps regulate or normalize the immune system.
  • Patients who are considered refractory to proteasome inhibitors cannot participate. Refractory means that the disease does not respond to treatment.
  • Patients who have received more than three previous treatments for Multiple Myeloma cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may include adults and older adults.
  • Patients who are not able to provide informed consent or who are part of a vulnerable population that requires special protection cannot participate.
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Investigated drugs

  • Venetoclax

    is a medication used in this trial to help treat multiple myeloma, a type of blood cancer. It works by targeting and blocking a specific protein that cancer cells need to survive, which may help to kill the cancer cells.

  • Daratumumab

    is an antibody therapy used in the trial. It attaches to a specific protein found on the surface of multiple myeloma cells. By doing this, it helps the immune system to identify and destroy these cancer cells.

  • Dexamethasone

    is a steroid medication included in the trial. It is used to reduce inflammation and suppress the immune system, which can help to manage symptoms and enhance the effectiveness of other cancer treatments.

  • Bortezomib

    is a medication that is sometimes added to the treatment combination in this trial. It works by interfering with the cancer cells' ability to break down proteins, which can lead to the death of these cells.

What is already known about the treatment

  • Venetoclax

    Venetoclax is administered orally and is currently being studied in combination with other medications for the treatment of relapsed or refractory multiple myeloma. It is a BCL-2 inhibitor, which works by blocking the protein that helps cancer cells survive, leading to their death. Venetoclax is classified as a targeted therapy and is being evaluated for its effectiveness in patients who have previously received other treatments.

  • Daratumumab

    Daratumumab is given as an intravenous infusion and is used in combination with other drugs for treating multiple myeloma, particularly in patients who have relapsed or are refractory to previous treatments. It is a monoclonal antibody that targets the CD38 protein on the surface of myeloma cells, helping the immune system to destroy them. Daratumumab is classified as an immunotherapy and is well-documented in medical literature for its role in multiple myeloma treatment.

  • Dexamethasone

    Dexamethasone is administered orally or intravenously and is used in combination with other medications for multiple myeloma. It is a corticosteroid that helps reduce inflammation and suppresses the immune response, which can help in controlling cancer growth. Dexamethasone is classified as an anti-inflammatory and immunosuppressant, and it is widely used in various cancer treatment protocols.

  • Bortezomib

    Bortezomib is administered via injection and is used in combination with other drugs for treating multiple myeloma, especially in patients who have relapsed or are refractory. It is a proteasome inhibitor that disrupts the degradation of proteins within cancer cells, leading to cell death. Bortezomib is classified as a targeted therapy and is well-established in the treatment of multiple myeloma.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to bone damage, anemia, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and kidney problems due to the accumulation of abnormal proteins produced by the cancerous cells. The disease often progresses in a relapsing and remitting pattern, where periods of active disease are followed by periods of remission. Over time, the disease can become resistant to treatment, making it more challenging to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506110-43-00Protocol codeM15-654Estimated enrolment72 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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