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Study Comparing Lenalidomide, Daratumumab, and Dexamethasone for Frail Patients with Untreated Multiple Myeloma Not 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 condition 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 for patients who have not received treatment before and are not suitable for high-dose therapy. One group will receive a combination of Lenalidomide and Daratumumab given as a subcutaneous injection, known as R-Dara SC. The other group will receive Lenalidomide and Dexamethasone, referred to as Rd. The purpose of the study is to see which combination is more effective in managing the disease.

Participants in the study will receive their assigned treatment over a period of time, with regular check-ups to monitor their health and the progress of the disease. The study will look at how long patients live without the disease getting worse, as well as other factors like overall survival and quality of life. The trial will also collect information on any side effects experienced by participants to ensure the safety of the treatments being tested.

This study is important for understanding how to best treat Multiple Myeloma in patients who are considered frail and cannot undergo more aggressive treatments. By comparing these two treatment options, researchers hope to find a more effective way to manage the disease and improve the quality of life for those affected. Participants will be closely monitored throughout the study to ensure their safety and well-being.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive a combination of lenalidomide and daratumumab or a combination of lenalidomide and dexamethasone.

  2. Step 2

    Treatment with lenalidomide and daratumumab

    If you are in the group receiving lenalidomide and daratumumab, you will take Revlimid 25 mg hard capsules orally. The dosage and frequency will be determined by your healthcare provider.

    You will also receive Darzalex 1800 mg solution for injection as a subcutaneous injection. The frequency and duration of these injections will be specified by your healthcare provider.

  3. Step 3

    Treatment with lenalidomide and dexamethasone

    If you are in the group receiving lenalidomide and dexamethasone, you will take Revlimid 25 mg hard capsules orally. The dosage and frequency will be determined by your healthcare provider.

    You will also take dexamethasone orally. The dosage and frequency will be specified by your healthcare provider.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and other necessary assessments to track your response to the treatment.

    You will be asked to complete quality of life questionnaires every three months during the first year and every six months thereafter until the end of the treatment.

  5. Step 5

    End of treatment

    The study is expected to continue until July 2026. Your participation will last until the end of the treatment or until your healthcare provider decides it is appropriate to stop.

    After completing the treatment, follow-up assessments will be conducted at 8 and 16 weeks to evaluate your health status.

Who can join the trial?

15 criteria

  • The person must be at least 65 years old.
  • The person must have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer. This must meet specific criteria, including:
    • Having a certain percentage of cancerous plasma cells in the bone marrow or a proven tumor made of these cells.
    • Having measurable levels of a specific protein in the blood or urine, which indicates the presence of the disease.
    • The person must be newly diagnosed and not suitable for high-dose chemotherapy with a stem cell transplant.
    • The person must have a Frailty Score of 2 or higher. This score assesses the person's overall health and ability to handle treatment.
    • Before starting the study, the person must have certain blood test results, including:
      • Hemoglobin level of at least 7.5 g/dL, which measures the amount of red blood cells.
      • Neutrophil count of at least 1.0 x 109/L, which measures a type of white blood cell.
      • Platelet count of at least 70 x 109/L, which helps with blood clotting.
      • Liver enzymes (AST and ALT) and bilirubin levels within specific limits.
      • Kidney function with a creatinine clearance of at least 30 mL/min.
      • Calcium level in the blood within a specific range.
      • The person must have measurable levels of certain proteins in the blood for study purposes.
      • If a man is sexually active with a woman who can become pregnant, he must agree to use a condom and not donate sperm during the study and for a specified time after the study drugs are stopped. Women in the study must be postmenopausal, meaning they have stopped having menstrual periods.
      • The person must sign a consent form indicating they understand the study and agree to participate.
      • The person must be part of a social security system.

Who cannot join the trial?

11 criteria

  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who have an active infection that needs treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of severe allergic reactions to any of the drugs used in the study.
  • Patients who have serious heart problems, such as heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have severe liver disease.
  • Patients who have severe kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate.
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Investigated drugs

  • Lenalidomide

    is a medication used in this study to treat multiple myeloma, a type of blood cancer. It works by helping the immune system attack cancer cells and by stopping the growth of new blood vessels that tumors need to grow. In this trial, lenalidomide is being tested in combination with other treatments to see how effective it is for patients who have not received high-dose therapy before.

  • Daratumumab Subcutaneous Injection

    is another treatment being tested in this study. It is a type of antibody therapy that targets a specific protein on the surface of cancer cells. By attaching to this protein, daratumumab helps the immune system find and destroy the cancer cells. In this trial, it is given as a subcutaneous injection, which means it is injected under the skin, and is being combined with lenalidomide to see if this combination is more effective for treating multiple myeloma.

  • Dexamethasone

    is a steroid medication used in this study to help reduce inflammation and suppress the immune system. It is often used in combination with other cancer treatments to help enhance their effectiveness. In this trial, dexamethasone is combined with lenalidomide to see how well this combination works for patients with multiple myeloma who are not eligible for high-dose therapy.

What is already known about the treatment

  • Lenalidomide

    Lenalidomide is taken orally in the form of capsules and is currently used in the treatment of multiple myeloma, a type of blood cancer. It is well-documented in medical literature as an effective therapy for this condition. The main therapeutic indication for lenalidomide is to help control the growth of cancer cells and improve survival rates. At the molecular level, lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It is classified as an immunomodulatory drug.

  • Daratumumab

    Daratumumab is administered as a subcutaneous injection and is used in the treatment of multiple myeloma. It is recognized in medical literature for its role in treating this type of cancer. The primary therapeutic indication for daratumumab is to target and destroy cancer cells in multiple myeloma patients. At the molecular level, daratumumab works by binding to a specific protein on the surface of cancer cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody.

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. It begins when a single plasma cell becomes abnormal and multiplies rapidly, leading to an accumulation of abnormal cells in the bone marrow. These abnormal cells produce a large amount of a single type of antibody, which can cause damage to bones and interfere with the production of normal blood cells. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The progression of the disease is often characterized by periods of stability followed by relapses, where symptoms worsen. Over time, the disease can become more aggressive and resistant to treatment.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-514088-25-00Protocol code2018_16Estimated enrolment294 patientsSponsorCentre Hospitalier Universitaire De Lille

sourced from the EU Clinical Trials Register and site verification

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