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Study on Treatment-Free Intervals for Newly Diagnosed Multiple Myeloma Patients Using Daratumumab, Lenalidomide, and Dexamethasone

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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 multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study will use a combination of three treatments: lenalidomide, daratumumab, and dexamethasone. Lenalidomide is taken as a capsule, daratumumab is given as an injection, and dexamethasone is taken as a soluble tablet. The purpose of the study is to explore the possibility of having a break from treatment for patients who have been newly diagnosed with multiple myeloma and have already received a specific combination of these treatments.

Participants in the study will be divided into two groups. One group will continue receiving the combination of daratumumab, lenalidomide, and dexamethasone without interruption. The other group will stop the treatment for a period and then resume it if there are signs that the disease is progressing. The study will monitor how long patients remain free from events like disease progression or the need to restart treatment, as well as their overall quality of life during the study period.

The trial aims to understand the effects of taking a break from treatment and how it impacts the progression of multiple myeloma. It will also look at the side effects and overall health of the participants. The study will help determine if a treatment-free interval is a viable option for managing multiple myeloma in newly diagnosed patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have been diagnosed with multiple myeloma and have completed 12 cycles of treatment with daratumumab, lenalidomide, and dexamethasone (Dara-Rd).

    The patient must be at least 18 years old and capable of providing informed consent.

  2. Step 2

    Randomization

    The patient will be randomly assigned to one of two groups: continuous therapy or discontinuation of therapy.

    In the continuous therapy group, the patient will continue receiving Dara-Rd until the disease progresses.

  3. Step 3

    Treatment administration

    For those in the continuous therapy group, lenalidomide is taken orally, with a reduced dose allowed but not less than 5 mg per day.

    Daratumumab is administered via subcutaneous injection.

    Dexamethasone is taken orally, with previous dose reductions allowed.

  4. Step 4

    Monitoring and evaluation

    The patient's health and response to treatment will be regularly monitored to assess event-free survival and progression-free survival.

    The study will evaluate the time to response and maximal response after restarting therapy in the discontinuation group.

  5. Step 5

    Treatment-free interval

    For patients in the discontinuation group, therapy will be paused until biochemical progression is observed.

    Upon progression, therapy with Dara-Rd will resume until further disease progression.

  6. Step 6

    End of study

    The study is estimated to conclude by September 8, 2030.

    The primary endpoints include event-free survival and progression-free survival, while secondary endpoints focus on quality of life, treatment-free intervals, and overall survival.

Who can join the trial?

7 criteria

  • The patient must have been diagnosed with multiple myeloma, a type of cancer that affects certain blood cells, based on specific criteria and have measurable disease at the time of diagnosis.
  • The patient must be at least 18 years old.
  • The patient must have been treated with 12 cycles (or 13 cycles) of a specific therapy called Dara-Rd and be eligible to continue this treatment. It's okay if the dose of one of the drugs, lenalidomide, was reduced, but it should not be less than 5 mg per day. Previous reduction or stopping of another drug, dexamethasone, is also allowed.
  • The patient must have achieved a partial response (PR) or better after 12 cycles of Dara-Rd treatment, without any signs of the disease getting worse based on lab tests.
  • The patient must have a certain level of white blood cells (ANC ≥ 1.0x109/L) and platelets (≥ 75x109/L), which are important for fighting infections and blood clotting.
  • The patient must be able to understand and agree to participate in the study, which means they can give informed consent.
  • The patient must provide written informed consent, which is a document that confirms they understand the study and agree to take part in it.

Who cannot join the trial?

4 criteria

  • Patients with conditions other than multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain blood cells in the bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range for this study is typically adults.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population, such as those unable to give consent, are not included in this study.
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Investigated drugs

  • Daratumumab

    is a medication used in the treatment of multiple myeloma. It works by targeting a specific protein on the surface of myeloma cells, helping the immune system to identify and destroy these cancerous cells.

  • Lenalidomide

    is a drug that helps to slow the growth of cancer cells and boosts the immune system to fight against multiple myeloma. It is often used in combination with other medications to enhance its effectiveness.

  • Dexamethasone

    is a type of steroid that reduces inflammation and helps to manage symptoms associated with multiple myeloma. It is commonly used alongside other treatments to improve patient outcomes.

What is already known about the treatment

  • Daratumumab

    This medication is administered intravenously and is currently being studied for its effectiveness in treating multiple myeloma. It is a monoclonal antibody that targets a specific protein on the surface of myeloma cells, helping the immune system to identify and destroy these cancerous cells. Daratumumab is classified as an anti-cancer agent and is widely recognized in medical literature for its role in multiple myeloma treatment.

  • Lenalidomide

    Taken orally, lenalidomide is used in the treatment of multiple myeloma and is well-documented in medical literature. It works by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug and is often used in combination with other medications to enhance its therapeutic effects.

  • Dexamethasone

    This medication is administered orally or intravenously and is commonly used in the treatment of multiple myeloma. It is a corticosteroid that reduces inflammation and suppresses the immune response, helping to alleviate symptoms and improve the effectiveness of other cancer treatments. Dexamethasone is classified as an anti-inflammatory and immunosuppressant agent.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, anemia, and increased susceptibility to infections. The abnormal cells can also produce a protein that can damage the kidneys. Over time, the disease can lead to complications such as kidney dysfunction and weakened bones. The progression of multiple myeloma varies among individuals, with periods of stability and periods of active disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508586-33-00Estimated enrolment599 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

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