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Study of Daratumumab with Drug Combination for Patients with Newly Diagnosed Multiple Myeloma Eligible for High-Dose Therapy

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 disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is comparing two different treatment combinations to see which is more effective for people who have not yet received treatment for this condition. One group will receive a combination of four medications: Daratumumab, VELCADE (also known as bortezomib), Lenalidomide, and Dexamethasone. The other group will receive three medications: VELCADE, Lenalidomide, and Dexamethasone. The purpose of the study is to determine if adding Daratumumab to the treatment will help patients live longer without their disease getting worse.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will involve taking medications either by mouth or through injections. The treatment period will last for a specific duration, and participants will be monitored regularly to assess their health and the progression of the disease. The study will also include follow-up visits to check on the participants' well-being and to gather information on how the treatments are working.

The study aims to provide valuable information on the effectiveness of these treatment combinations for Multiple Myeloma. By comparing the two groups, researchers hope to find out if the addition of Daratumumab can improve outcomes for patients. This research could lead to better treatment options for those affected by this type of cancer in the future.

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 participant is randomly assigned to one of two treatment groups. The study aims to compare the effectiveness of two different treatment combinations for multiple myeloma.

  2. Step 2

    Treatment group assignment

    Participants are assigned to either the combination of daratumumab, VELCADE (bortezomib), lenalidomide, and dexamethasone (D-VRd) or the combination of VELCADE, lenalidomide, and dexamethasone (VRd).

  3. Step 3

    Medication administration

    For those in the D-VRd group, daratumumab is administered as a subcutaneous injection at a dose of 1800 mg.

    VELCADE is given as a subcutaneous injection at a dose of 3.5 mg.

    lenalidomide is taken orally in capsule form, with doses of 15 mg, 10 mg, or 5 mg depending on the treatment phase.

    dexamethasone is also part of the treatment regimen.

  4. Step 4

    Treatment schedule

    The treatment is administered in cycles, with specific dosages and schedules for each medication. The frequency and duration of each medication depend on the treatment phase and the participant's response to the therapy.

  5. Step 5

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring and assessments to evaluate the effectiveness of the treatment and to check for any side effects. This includes blood tests, imaging studies, and other evaluations as needed.

  6. Step 6

    End of treatment

    The study is estimated to conclude by May 24, 2029. Participants will continue to be monitored for their response to the treatment and any long-term effects.

Who can join the trial?

13 criteria

  • Participants must be between 18 and 70 years old.
  • Men who can have children and are sexually active with women who can also have children must always use a latex or synthetic condom during the study and for 3 months after stopping the study treatment, even if they have had a vasectomy.
  • Men who can have children must not donate sperm during the study and for 3 months after the last dose of study treatment.
  • Participants must sign a form indicating they understand the study and agree to participate. If they cannot sign due to an emergency, they cannot join the study.
  • Participants must be able to follow the rules and restrictions of the study.
  • Participants must have a certain amount of abnormal plasma cells in their bone marrow or a specific type of tumor called a plasmacytoma. They must also meet certain health criteria related to calcium levels, kidney function, anemia, or bone damage.
  • Participants must have a measurable disease, which means certain levels of specific proteins in their blood or urine.
  • Participants must be newly diagnosed and planning to undergo high-dose therapy and a procedure called autologous stem cell transplantation.
  • Participants must have a performance status score of 0, 1, or 2, which is a measure of their ability to perform daily activities.
  • Participants must have adequate bone marrow, liver, and kidney function based on specific laboratory tests.
  • Women who can have children must agree to either not have heterosexual intercourse or use two reliable birth control methods during the study and for 3 months after the last dose of treatment. One method must be highly effective, like an IUD or hormonal birth control, and the other can be a condom or similar method.
  • Women who can have children must have two negative pregnancy tests before starting the study treatment.
  • Women must agree not to donate eggs for assisted reproduction during the study and for 3 months after the last dose of treatment.
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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. In this trial, daratumumab is being tested to see if it can improve the outcomes for patients when added to a standard treatment regimen.

  • VELCADE (bortezomib)

    is a medication that helps treat multiple myeloma by interfering with the growth of cancer cells. It works by blocking a certain protein that cancer cells need to grow and multiply. VELCADE is part of the standard treatment regimen being compared in this trial.

  • Lenalidomide

    is a medication that modifies the immune system and has anti-cancer effects. It is used to treat multiple myeloma by slowing down or stopping the growth of cancer cells. Lenalidomide is included in the standard treatment regimen in this study.

  • Dexamethasone

    is a type of steroid that helps reduce inflammation and suppresses the immune system. In the context of multiple myeloma, it is used to help control the disease and manage symptoms. Dexamethasone is part of the standard treatment regimen being evaluated in this trial.

What is already known about the treatment

Daratumumab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. It is already approved for use in certain cases of multiple myeloma and is well-documented in medical literature. Daratumumab works by targeting a specific protein on the surface of cancer cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

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 and kidneys. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also crowd out healthy blood cells, leading to further complications. Over time, the disease can cause significant damage to the body's organs and systems, affecting overall health and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506125-10-00Protocol codeEMN1754767414MMY3014Estimated enrolment831 patientsSponsorEmn Trial Office S.r.l. Impresa Sociale

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