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Study on Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone for Patients with Newly Diagnosed Systemic AL Amyloidosis

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 AL Amyloidosis, specifically in patients who have been newly diagnosed with this disease. AL Amyloidosis is a rare condition where abnormal proteins, known as amyloids, build up in organs and tissues, affecting their normal function. The study aims to evaluate the effectiveness and safety of a treatment combination that includes the drug Daratumumab, along with Cyclophosphamide, Bortezomib, and Dexamethasone. These medications are used to target and reduce the amyloid proteins in the body.

Participants in the study will be randomly assigned to receive either the combination of Daratumumab with Cyclophosphamide, Bortezomib, and Dexamethasone, or the combination of Cyclophosphamide, Bortezomib, and Dexamethasone alone. The study will compare the two groups to see which treatment is more effective in managing AL Amyloidosis. The trial will last for a period of up to 36 months, during which participants will receive regular treatments and monitoring to assess their response to the therapy.

The primary goal of the study is to determine the overall complete hematologic response rate, which means evaluating how well the treatment works in reducing the levels of abnormal proteins in the blood. This study is important for understanding better treatment options for people with newly diagnosed AL Amyloidosis and aims to improve the quality of life for those affected by this condition.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups. One group will receive a combination of daratumumab, cyclophosphamide, bortezomib, and dexamethasone (referred to as CyBorD), while the other group will receive CyBorD alone.

    The purpose of this study is to evaluate the effectiveness and safety of adding daratumumab to the CyBorD treatment regimen for patients with newly diagnosed systemic AL amyloidosis.

  2. Step 2

    Treatment administration

    The patient will receive bortezomib as a subcutaneous injection. The dosage and frequency will be determined by the study protocol.

    The patient will take cyclophosphamide orally in the form of coated tablets. The dosage and frequency will be specified in the study protocol.

    If assigned to the group receiving daratumumab, the patient will receive it as a subcutaneous injection. The dosage and frequency will be outlined in the study protocol.

    The patient will take dexamethasone orally in the form of tablets. The dosage and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular check-ups and tests to assess the effectiveness of the treatment and to identify any side effects.

    The primary goal is to achieve a complete hematologic response, which means the disease is no longer detectable in the blood.

  4. Step 4

    Study completion

    The study is expected to conclude by December 31, 2024. At the end of the study, the patient's overall response to the treatment will be evaluated.

    The results will help determine the effectiveness of adding daratumumab to the CyBorD regimen for treating newly diagnosed systemic AL amyloidosis.

Who can join the trial?

11 criteria

  • You must be **18 years or older** to participate.
  • If you are a woman who can have children, you need to have a **negative pregnancy test** before joining the study.
  • You must **agree to participate** in the study by signing a consent form, which means you understand what the study is about and what you need to do.
  • You need to have a **diagnosis of amyloidosis**, which is confirmed by specific tests on tissue samples.
  • You must have a **measurable disease** related to amyloidosis, which can be identified through certain blood tests.
  • At least **one organ** in your body must be affected by amyloidosis.
  • Your **physical health status** should be at a level where you can perform daily activities with some limitations.
  • Your **blood test results** must meet specific criteria, such as having enough white blood cells, red blood cells, and platelets, and normal liver and kidney function.
  • If you are a woman who can have children, you must agree to use **reliable birth control** methods during the study and for a certain period after the study ends.
  • During the study and for a certain period after, you must agree **not to donate eggs** if you are a woman.
  • If you are a man, you must agree to use **birth control methods** if you are sexually active with a woman who can have children, and you must not donate sperm during the study and for a certain period after.

Who cannot join the trial?

7 criteria

  • Patients who have been diagnosed with a different type of amyloidosis other than **AL Amyloidosis**.
  • Patients who have already received treatment for **AL Amyloidosis**.
  • Patients who have serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial.
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Investigated drugs

  • Daratumumab

    is a medication used in this trial to treat patients with newly diagnosed systemic AL amyloidosis. It is being tested to see if it works better when combined with other medications compared to using those medications alone. Daratumumab is known to help the immune system target and destroy certain abnormal cells.

  • Cyclophosphamide

    is a chemotherapy drug that is part of the treatment combination being studied. It works by slowing or stopping the growth of abnormal cells in the body, which can help manage the disease.

  • Bortezomib

    is another medication included in the treatment combination. It helps to prevent the breakdown of proteins in cells, which can lead to the death of abnormal cells. This can be beneficial in treating conditions like AL amyloidosis.

  • Dexamethasone

    is a type of steroid used in the trial. It helps reduce inflammation and can also help enhance the effects of other medications in the treatment combination. It is used to help manage symptoms and improve the overall effectiveness of the treatment.

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 newly diagnosed systemic AL amyloidosis. It is a monoclonal antibody that targets a specific protein on the surface of certain cells, helping the immune system to identify and destroy these cells. Daratumumab is classified as an anti-cancer drug and is primarily used in combination with other medications to enhance its therapeutic effects.

  • Cyclophosphamide

    Administered orally or intravenously, cyclophosphamide is a well-established medication used in the treatment of various cancers and autoimmune disorders. It works by interfering with the DNA replication process in rapidly dividing cells, leading to cell death. Cyclophosphamide is classified as an alkylating agent and is part of the combination therapy being evaluated for AL amyloidosis.

  • Bortezomib

    This medication is given by injection and is used in the treatment of multiple myeloma and other blood disorders. Bortezomib works by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, leading to the accumulation of proteins and cell death. It is classified as a proteasome inhibitor and is included in the combination therapy for AL amyloidosis.

  • Dexamethasone

    Administered orally or by injection, dexamethasone is a corticosteroid used to reduce inflammation and suppress the immune system. It is often used in combination with other medications to treat a variety of conditions, including certain types of cancer. Dexamethasone helps to enhance the effects of other drugs in the treatment regimen for AL amyloidosis.

Investigated diseases

AL Amyloidosis – AL Amyloidosis is a rare disease characterized by the abnormal deposition of amyloid proteins in various tissues and organs. This condition primarily affects the heart, kidneys, liver, and nervous system, leading to organ dysfunction. The disease progresses as these amyloid deposits accumulate, causing the affected organs to gradually lose their ability to function properly. Symptoms can vary widely depending on which organs are involved, but may include fatigue, swelling, and weight loss. Over time, the increasing amyloid burden can lead to more severe organ impairment. Early diagnosis and management are crucial to slow the progression of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511967-26-00Protocol code54767414AMY3001Estimated enrolment344 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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