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Study of Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone for Patients with Newly Diagnosed AL Amyloidosis with Heart Involvement

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 Amyloid Light Chain (AL) Amyloidosis. This is a disease where abnormal proteins, known as amyloids, build up in organs and tissues, which can affect their normal function. The study is testing a combination of treatments that include Daratumumab, Bortezomib (marketed as VELCADE), Cyclophosphamide, and Dexamethasone Sodium Phosphate. These medications are used to target and reduce the amyloid deposits in the body.

The purpose of the study is to understand the safety of these treatments, especially concerning the heart, in people who have been newly diagnosed with AL Amyloidosis that affects the heart. The study also aims to find ways to reduce any heart-related side effects and to understand how the body processes Daratumumab, particularly in racial and ethnic minority groups. Participants in the study will receive these medications through injections or infusions over a period of time, and their health will be monitored closely to observe any changes or improvements in their condition.

Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study will help gather important information on how effective and safe these treatments are for managing AL Amyloidosis, with a focus on improving heart health and overall survival. The findings from this study could lead to better treatment strategies for people living with this condition.

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, eligibility is confirmed based on specific criteria, including age and medical condition.

    Participants must agree to follow certain guidelines regarding contraception and donation of reproductive materials during and after the study.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of medications: bortezomib, daratumumab, cyclophosphamide, and dexamethasone sodium phosphate.

    Bortezomib and daratumumab are administered through subcutaneous injections.

    Cyclophosphamide and dexamethasone sodium phosphate are given intravenously.

  3. Step 3

    Treatment regimen

    The treatment is designed to assess cardiac safety and identify strategies to reduce heart-related side effects.

    The study also aims to understand how daratumumab behaves in the body, especially among racial and ethnic minorities.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to track the incidence of any heart-related events and other side effects.

    The effectiveness of the treatment is evaluated through various measures, including response rates and overall survival.

  5. Step 5

    Completion of treatment

    The study is expected to continue until February 2028, with ongoing assessments to determine the long-term outcomes of the treatment.

    Participants are monitored for any lasting effects or need for additional treatment.

Who can join the trial?

17 criteria

  • Must be at least 18 years old.
  • If a female participant can have children, she must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
  • If a female participant can have children, she must either not be able to have children or use effective birth control methods starting 4 weeks before the study and continuing for 1 year after stopping cyclophosphamide or 100 days after stopping daratumumab, whichever is longer.
  • Male participants must use a condom during any activity that could result in pregnancy during the study and for 6 months after stopping cyclophosphamide or 100 days after stopping daratumumab, whichever is longer. If the male participant has had a vasectomy, he still needs to use a condom, but his partner does not need to use birth control.
  • Female participants must agree not to donate eggs or freeze them for future use during the study and for at least 1 year after the last dose of cyclophosphamide or 100 days after stopping daratumumab, whichever is longer.
  • Male participants must agree not to donate sperm during the study and for at least 6 months after the last dose of cyclophosphamide or 100 days after stopping daratumumab, whichever is longer.
  • Must sign an informed consent form, which means agreeing to participate in the study after understanding all the details.
  • For Cohort 2 only: Must identify as a racial or ethnic minority, including Black or African American.
  • Must have a new diagnosis of **systemic AL amyloidosis**, which is a condition where a protein called amyloid builds up in organs, based on specific medical tests.
  • For Cohort 1: Must have heart involvement with AL amyloidosis, with or without other organs involved. For Cohort 2: Must have one or more organs affected by systemic AL amyloidosis.
  • Must have an **ECOG Performance Status** score of 0, 1, or 2, which measures how well a person can perform daily activities.
  • Must have certain blood test results within specific ranges before starting the study, including:
    • Hemoglobin level of at least 8.0 g/dL; blood transfusions are allowed until 7 days before joining the study.
    • Platelet count of at least 50,000 per microliter; platelet transfusions are allowed until 7 days before joining the study.
    • Absolute Neutrophil Count of at least 1,000 per microliter.
    • Levels of liver enzymes (AST and ALT) no more than 2.5 times the upper limit of normal.
    • Total bilirubin level no more than 1.5 times the upper limit of normal, except for those with certain conditions like Gilbert syndrome.
    • Estimated kidney function (glomerular filtration rate) of at least 20 mL/min/1.73 m².

Who cannot join the trial?

8 criteria

  • Patients who have a different type of amyloidosis other than Amyloid Light Chain Amyloidosis cannot participate. Amyloidosis is a condition where abnormal proteins build up in tissues and organs.
  • Patients who have not been newly diagnosed with systemic AL amyloidosis are excluded. "Systemic" means it affects the whole body.
  • Patients without cardiac involvement are excluded. "Cardiac involvement" means the heart is affected by the condition.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study.
  • Patients who are not part of the specified clinical trial group are excluded. Clinical trial groups are specific categories of patients the study is focusing on.
  • Patients who are not able to provide informed consent are excluded. Informed consent means understanding the study and agreeing to participate.
  • Patients who are pregnant or breastfeeding are excluded to avoid any potential risks to the baby.
  • Patients with other serious health conditions that could interfere with the study are excluded. This is to ensure the safety of the participants and the accuracy of the study results.
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Investigated drugs

  • Daratumumab

    is a medication used in this study to treat patients with a condition called AL amyloidosis. It is designed to help the immune system target and destroy abnormal cells that are causing the disease. In this trial, daratumumab is given to participants to see how well it works and to monitor its safety, especially concerning the heart.

  • VCd Therapy

    is a combination of medications used alongside daratumumab in this study. It includes a mix of drugs that work together to treat AL amyloidosis by targeting the disease in different ways. The goal is to improve the effectiveness of the treatment and manage symptoms more effectively.

What is already known about the treatment

Daratumumab – This medication is administered as a subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating Amyloid Light Chain (AL) Amyloidosis. It is a monoclonal antibody that targets a specific protein on the surface of certain cells, helping the immune system to destroy these cells. Daratumumab is classified as an immunotherapy drug and is primarily used in the treatment of multiple myeloma, with ongoing research exploring its potential benefits for AL amyloidosis.

Investigated diseases

Amyloid Light Chain Amyloidosis – This is a rare disease where abnormal proteins, known as light chains, build up in organs and tissues, disrupting their normal function. The condition often affects the heart, kidneys, liver, and nerves, leading to a variety of symptoms depending on the organs involved. In the heart, it can cause thickening of the heart walls, leading to heart failure and irregular heartbeats. In the kidneys, it may result in protein loss in the urine and kidney dysfunction. The disease progresses as more organs become affected by the protein deposits, leading to increased symptoms and complications. The progression and severity of symptoms can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507069-25-00Protocol code54767414AMY2009Estimated enrolment190 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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