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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Lyon Sud Pierre Benite France
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Ukuwjaixytgy Mhhrdnj Cbuddjp Gqjallyfc Groningen The Netherlands
Iofatmpe Cospqz Dabdxlygppxivagew L'hospitalet De Llobregat Spain
Hrsfxhpj Vwmk dqryruly Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
10.06.2022
Germany Germany
Not recruiting
10.06.2022
Greece Greece
Not recruiting
10.06.2022
Italy Italy
Not recruiting
10.06.2022
Spain Spain
Not recruiting
10.06.2022
The Netherlands The Netherlands
Not recruiting
10.06.2022

Trial locations

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.

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 ID:
2023-507069-25-00
Protocol code:
54767414AMY2009
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of Teclistamab for Patients with Previously Treated AL Amyloidosis

    Recruiting

    2 1 1
    Investigated drugs:
    France Germany Greece Italy The Netherlands
  • Study on the Safety and Effectiveness of Linvoseltamab, Sarilumab, and Dexamethasone in Adults with Relapsed or Refractory AL Amyloidosis

    Recruiting

    1 1 1 1
    Greece Spain