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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Institut Jules Bordet	Anderlecht	Belgium
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universitair Ziekenhuis Gent	Gent	Belgium
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
HOPA MVZ GmbH	Hamburg	Germany
Maxima Medisch Centrum	Veldhoven	The Netherlands
Odense University Hospital	Odense	Denmark
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Semmelweis University	Budapest	Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Region Midtjylland	Aarhus	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Uqayvzktjjlgysbegluae Eobqc Avc	Essen	Germany
Urrffpwkomvq Mjglfki Cvwuxar Ggxrnafrb	Groningen	The Netherlands
Chitvs Hnxdkjjqxii Ee Unufzmowdxttj Df Lmhxnbk	Limoges	France
Awnefnsdas Pxluassm Hviscuka Dt Psgij	Paris	France
Cexvsb Hditmoykzki Razionoq Usmjuwknrastv Dg Tjune	Tours	France
Cjhm Df Nydgh	Vandoeuvre Les Nancy	France
Uxjwsccuoo Dtdvb Sjunt Dj Rjlr Lj Sueehwwf	Rome	Italy
Inocuryu Ccjtfi Dyehjgmnjztjzqptf	L'hospitalet De Llobregat	Spain
Hezkzljq Vwmo dwlxyxjg	Barcelona	Spain
Ignhyxxz Pbniyczxiyldyvw Ckchua Coxqnb	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	17.04.2018
Denmark	Not recruiting	17.04.2018
France	Not recruiting	17.04.2018
Germany	Not recruiting	17.04.2018
Greece	Not recruiting	17.04.2018
Hungary	Not recruiting	17.04.2018
Italy	Not recruiting	17.04.2018
Poland	Not recruiting	17.04.2018
Spain	Not recruiting	17.04.2018
Sweden	Not recruiting	17.04.2018
The Netherlands	Not recruiting	17.04.2018

Trial locations

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.

Investigated diseases:

Primary amyloidosis

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 ID:

2024-511967-26-00

Protocol code:

54767414AMY3001

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?