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Study Comparing Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Patients with Untreated Multiple Myeloma Not Planning Stem Cell Transplant

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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 cancer that affects plasma cells in the bone marrow. The study is comparing two treatment combinations for patients who have not yet received treatment for this condition and are not planning to undergo a stem cell transplant as their initial therapy. The first treatment combination includes Daratumumab, VELCADE (also known as Bortezomib), Lenalidomide, and Dexamethasone, referred to as D-VRd. The second combination includes VELCADE, Lenalidomide, and Dexamethasone, referred to as VRd. The purpose of the study is to determine if adding Daratumumab to the VRd combination improves the rate at which patients achieve a state called minimal residual disease (MRD) negativity, which means that no cancer cells can be detected in the bone marrow.

Participants in the study will receive one of the two treatment combinations. The study will monitor the participants over a period to see how well the treatments work in reducing the presence of cancer cells. The treatments involve taking medications in the form of capsules or injections. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study aims to provide valuable information on the effectiveness of these treatment combinations for patients with Multiple Myeloma.

The trial will continue until 2028, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments. This study is important for understanding how to best treat Multiple Myeloma in patients who are not candidates for stem cell transplants. By participating in this study, researchers hope to improve treatment options and outcomes for individuals affected by this type of cancer.

The research process

The trial runs in 4 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 several medications. The medications include Revlimid (lenalidomide) in various dosages, VELCADE (bortezomib), DARZALEX (daratumumab), and dexamethasone.

    Revlimid is taken orally in capsule form. The dosages vary between 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, depending on the specific treatment plan.

    VELCADE is administered as a subcutaneous injection. The dosage is 3.5 mg.

    DARZALEX is also given as a subcutaneous injection, with a dosage of 1800 mg.

    Dexamethasone is taken orally in tablet form.

  2. Step 2

    Treatment schedule

    The treatment schedule is structured in cycles. Each cycle typically lasts for a specified period, during which the medications are administered according to the protocol.

    The frequency and duration of each medication depend on the cycle and the specific treatment plan. It is important to adhere to the schedule as prescribed.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments are conducted to evaluate the response to treatment.

    These assessments may include blood tests, imaging studies, and other evaluations to monitor the condition and adjust treatment as necessary.

  4. Step 4

    Completion of treatment

    Upon completion of the treatment cycles, a final assessment is conducted to determine the overall response to the treatment.

    The primary objective is to achieve minimal residual disease (MRD) negativity, which indicates a significant reduction in disease presence.

Who can join the trial?

12 criteria

  • Must be newly diagnosed with Multiple Myeloma and not suitable for high-dose chemotherapy with stem cell transplantation. This could be due to being 65 years or older, having other health conditions that make chemotherapy risky, or choosing not to have chemotherapy.
  • Must have a confirmed diagnosis of Multiple Myeloma. This means having a certain number of abnormal plasma cells in the bone marrow or meeting specific criteria related to calcium levels, kidney function, anemia, or bone damage.
  • Must have a measurable disease, which means certain proteins related to Multiple Myeloma can be detected in the blood or urine.
  • Must have an ECOG performance status score of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities.
  • Must have specific laboratory test results, such as certain levels of hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, kidney function, and calcium.
  • Female participants who can have children must agree to use two reliable methods of birth control or abstain from heterosexual intercourse during the study and for three months after the last dose of treatment.
  • Female participants must have two negative pregnancy tests before starting the study.
  • Female participants must agree not to donate eggs for assisted reproduction during the study and for three months after the last dose of treatment.
  • Male participants must agree not to donate sperm during the study and for three months after the last dose of treatment.
  • Male participants who are sexually active with females who can have children must always use a latex or synthetic condom during the study and for three months after stopping the treatment.
  • Must sign an informed consent form, indicating understanding of the study and willingness to participate.
  • Must be able to follow the rules and restrictions of the study.

Who cannot join the trial?

10 criteria

  • Patients with any other active cancer besides Multiple Myeloma cannot participate.
  • Patients who have had a heart attack or severe heart problems in the past 6 months are excluded.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Patients with severe kidney disease or those on dialysis cannot join the study.
  • Patients with severe liver disease are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with active infections that require treatment are not eligible.
  • Patients who have received another investigational drug within the last 30 days are excluded.
  • Patients with known allergies to the study drugs cannot participate.
  • Patients with a history of drug or alcohol abuse in the past year are not eligible.
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Investigated drugs

  • Daratumumab

    is a medication used in this study to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this trial, it is being tested to see if adding it to the standard treatment can improve outcomes for patients.

  • VELCADE

    (bortezomib) is a medication that helps treat multiple myeloma by interfering with the growth of cancer cells. It is part of the standard treatment regimen in this study and is used to help control the disease and improve patient outcomes.

  • Lenalidomide

    is a medication that modifies the immune system and has anti-cancer effects. It is commonly used in the treatment of multiple myeloma and is part of the standard treatment regimen in this study. It helps to slow down or stop the growth of cancer cells.

  • Dexamethasone

    is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma treatment, it helps to enhance the effects of other cancer medications and manage symptoms associated with the disease.

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.

  • Bortezomib

    This medication is given as an injection under the skin or into a vein and is used in the treatment of multiple myeloma. It is well-established in medical practice and literature for its role in cancer therapy. Bortezomib works by inhibiting the proteasome, a complex that breaks down proteins in cells, leading to cancer cell death. It is classified as a proteasome inhibitor.

  • Lenalidomide

    Administered orally in capsule form, this medication is used to treat multiple myeloma and is widely recognized in medical literature. Lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory agent.

  • Dexamethasone

    This medication is taken orally or administered intravenously and is used in combination with other drugs to treat multiple myeloma. It is a well-known medication in medical literature and practice. Dexamethasone works by reducing inflammation and suppressing the immune response, which can help control cancer growth. It is classified as a corticosteroid.

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 problems such as anemia, infections, and bone damage. As the disease progresses, it can cause bone pain, fractures, and high levels of calcium in the blood. The abnormal plasma cells can also produce a protein that can damage the kidneys. Over time, the disease can lead to weakened bones and increased risk of infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507312-13-00Protocol code54767414MMY3019Estimated enrolment395 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).