Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study Comparing Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone with Ciltacabtagene Autoleucel or Stem Cell Transplant for Newly Diagnosed Multiple Myeloma Patients

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will compare two treatment approaches for patients who are newly diagnosed and eligible for a stem cell transplant. The first approach involves a combination of medications: Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (referred to as DVRd), followed by a treatment called Ciltacabtagene Autoleucel, which is a type of cell therapy. The second approach uses the same combination of medications (DVRd) followed by an Autologous Stem Cell Transplant (ASCT), where a patient's own stem cells are used to help restore healthy bone marrow.

The purpose of the study is to compare the effectiveness of these two treatment strategies. Participants will receive either the DVRd treatment followed by Ciltacabtagene Autoleucel or the DVRd treatment followed by ASCT. The study will monitor the progress of the disease and the response to treatment over time. Participants will be closely observed to see how well the treatments work in controlling the disease and maintaining remission, which means the cancer is not active.

Throughout the study, participants will receive regular medical check-ups and assessments to ensure their safety and to track the effectiveness of the treatments. The study aims to provide valuable information on which treatment approach may offer better outcomes for patients with newly diagnosed Multiple Myeloma. Participants will be randomly assigned to one of the two treatment groups, and some may receive a placebo as part of the study design. The trial is expected to continue for several years to gather comprehensive data on the long-term effects and benefits of the treatments being studied.

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 treatment phase

    The initial treatment phase involves the administration of a combination of medications. These include daratumumab, bortezomib, lenalidomide, and dexamethasone.

    Daratumumab is given as a solution for injection under the skin. Bortezomib is also administered as a solution for injection.

    Lenalidomide is provided in capsule form and taken orally. Dexamethasone is available in tablet form and is also taken orally.

  2. Step 2

    Treatment continuation

    The treatment continues with the same combination of medications: daratumumab, bortezomib, lenalidomide, and dexamethasone.

    The administration routes and forms remain the same as in the initial phase.

  3. Step 3

    Treatment comparison

    Participants are divided into two groups for comparison. One group receives ciltacabtagene autoleucel, a dispersion for infusion administered intravenously.

    The other group undergoes an autologous stem cell transplant (ASCT), which involves using the participant's own stem cells.

  4. Step 4

    Consolidation phase

    Following the comparison phase, participants continue with lenalidomide therapy.

    This phase aims to consolidate the treatment effects and is crucial for long-term outcomes.

  5. Step 5

    Follow-up and monitoring

    Participants are monitored for progression-free survival (PFS) and sustained minimal residual disease (MRD)-negative complete response (CR).

    Regular assessments are conducted to evaluate the overall response and any adverse effects.

Who can join the trial?

6 criteria

  • Must be 18 years of age or older.
  • Must have a confirmed diagnosis of Newly Diagnosed Multiple Myeloma (NDMM), which is a type of blood cancer, according to specific medical guidelines.
  • High-dose therapy and Autologous Stem Cell Transplant (ASCT) should be part of the planned initial treatment. ASCT is a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow.
  • Must have a measurable disease, which means the disease can be measured by certain tests. This includes having a specific level of a protein in the blood or urine, or a certain level of free light chains in the blood, which are parts of antibodies.
  • Must have an ECOG performance status of grade 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Must have certain clinical laboratory values within a specified range, as detailed in the study protocol.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain 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.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have certain medical conditions that might interfere with the study cannot participate. These conditions are usually those that could make the study unsafe for the patient.
  • Patients who are pregnant or breastfeeding cannot participate, as the study treatments might affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
  • Patients who have had certain treatments for Multiple Myeloma before may not be eligible to participate.
  • Patients who have allergies to any of the study medications cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Daratumumab

    is a medication used to treat multiple myeloma, a type of blood cancer. It works by helping the immune system to identify and destroy cancer cells.

  • Bortezomib

    is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body. It is used to treat multiple myeloma.

  • Lenalidomide

    is a medication that affects the immune system. It promotes immune responses to help slow down the growth of cancer cells. It is used in the treatment of multiple myeloma.

  • Dexamethasone

    is a type of steroid that helps reduce inflammation and is used in combination with other medications to treat multiple myeloma.

  • Ciltacabtagene Autoleucel

    is a type of gene therapy used in the treatment of multiple myeloma. It involves modifying a patient's own immune cells to better recognize and attack cancer cells.

  • Autologous Stem Cell Transplant (ASCT)

    is a procedure in which a patient's own stem cells are collected, stored, and then given back to the patient after intensive treatment. This helps to restore the bone marrow and immune system.

What is already known about the treatment

  • Daratumumab

    This medication is administered intravenously and is currently well-established in medical literature for the treatment of multiple myeloma. It is primarily used to target and destroy cancerous plasma cells in the bone marrow. Daratumumab works by binding to a specific protein on the surface of these cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody.

  • Bortezomib

    Administered either intravenously or subcutaneously, bortezomib is a well-known treatment for multiple myeloma. It helps to slow or stop the growth of cancer cells by inhibiting a protein complex that breaks down unneeded proteins in cells. This action disrupts the cell cycle and leads to cancer cell death. Bortezomib is classified as a proteasome inhibitor.

  • Lenalidomide

    Taken orally, lenalidomide is widely used in the treatment of multiple myeloma. It works by enhancing the immune system's ability to fight cancer and by directly inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory agent.

  • Dexamethasone

    This medication is administered orally or intravenously and is commonly used in combination with other drugs to treat multiple myeloma. It acts as an anti-inflammatory and immunosuppressant, helping to reduce inflammation and modulate the immune response. Dexamethasone is classified as a corticosteroid.

  • Ciltacabtagene Autoleucel

    Administered as a single infusion, this medication is an emerging therapy in the treatment of multiple myeloma. It involves modifying a patient's own T-cells to better recognize and attack cancer cells. This personalized approach is part of a class of treatments known as CAR T-cell therapies.

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. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and weakness. Over time, the disease can cause significant complications, including kidney dysfunction and bone lesions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507632-20-00Protocol codeEMN2868284528MMY3005Estimated enrolment806 patientsSponsorEmn Trial Office S.r.l. Impresa Sociale

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.