Study of Belantamab Mafodotin for Patients with Relapsed or Refractory AL Amyloidosis

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What is this study about?

This clinical trial is focused on studying a condition known as AL amyloidosis, which is a rare disease that occurs when a protein called amyloid builds up in organs and tissues, affecting their normal function. The study is specifically looking at patients whose disease has returned after treatment or has not responded to previous treatments, referred to as “relapsed or refractory” cases. The treatment being tested in this trial is a medication called Belantamab Mafodotin, which is administered as a powder mixed into a solution for injection.

The purpose of the study is to evaluate how effective Belantamab Mafodotin is in treating patients with relapsed or refractory AL amyloidosis. Participants in the study will receive the medication through an intravenous injection, which means it is given directly into a vein. The study will monitor the participants over a period of time to see how their condition responds to the treatment. This includes checking for any changes in the disease and observing any side effects that may occur.

Throughout the study, researchers will collect data to understand the safety and effectiveness of Belantamab Mafodotin. The trial aims to provide valuable information that could lead to better treatment options for people with this challenging condition. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the course of the study.

1 Joining the study

Upon joining the study, the patient will be informed about the trial procedures and will provide written consent to participate.

Eligibility will be confirmed based on specific criteria, including age, previous treatments, and health status.

2 Initial assessment

An initial assessment will be conducted to evaluate the patient’s health status and confirm the diagnosis of AL amyloidosis.

This assessment may include blood tests, imaging, and other diagnostic procedures.

3 Treatment administration

The patient will receive the medication belantamab mafodotin, which is a powder for solution for injection.

The medication will be administered through an intravenous route, meaning it will be given directly into a vein.

The treatment will be given in cycles, with each cycle lasting a specific period as determined by the study protocol.

4 Monitoring and follow-up

Throughout the trial, the patient’s response to the treatment will be closely monitored.

Regular follow-up visits will be scheduled to assess the effectiveness of the treatment and to check for any side effects.

The primary goal is to evaluate the response rate at 6 months or after 4 cycles of therapy.

5 Completion of the trial

The trial is expected to continue until July 2025, with the patient’s participation lasting until the end of the study or until the treatment is completed.

Upon completion, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Must have a confirmed diagnosis of AL amyloidosis. This is a condition where abnormal proteins build up in organs and tissues.
Must have had at least two cycles of treatment aimed at the plasma cell clone, or have received high-dose therapy with melphalan as the only treatment.
Must be 18 years of age or older.
Must have an ECOG performance status of 0, 1, or 2. This is a scale that measures how well a patient can perform daily activities.
Must be in Mayo stage 1, 2, or 3A1-3. This refers to the severity of the disease based on specific blood test results.
Must have a supine systolic blood pressure of at least 90 mmHg. This is the blood pressure when lying down.
Must have measurable disease, which means having certain levels of specific proteins in the blood.
Must have symptoms affecting organs like the heart, kidneys, liver, or nervous system.
Must have adequate organ function, meaning the organs are working well enough.
Must provide written informed consent, which means agreeing to participate after understanding the study details.
Female patients must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
Male patients must agree to use birth control methods and not donate sperm during the study and for a period after.
Any side effects from previous treatments must be mild (Grade 1 or less), except for hair loss.
Must be able to understand the study procedures and agree to participate by signing a consent form.

Who Cannot Join the Study?

Patients who do not have relapsed or refractory AL amyloidosis cannot participate. This means the condition has returned after treatment or did not respond to treatment.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who belong to a clinical trial group that is not included in this study cannot participate. This refers to specific groups of patients that the study is focusing on.
Patients who are not male or female cannot participate, as the study includes both genders.
Patients who are part of a vulnerable population that is not selected for this study cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who need special protection in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Alexandra Hospital	Athens	Greece
Cvuixe Hshxvxqinjg El Ukqlcgomygcih Da Lwrhrck	Limoges	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.03.2021
Germany	Not recruiting	01.03.2021
Greece	Not recruiting	01.03.2021
Italy	Not recruiting	01.03.2021
The Netherlands	Not recruiting	01.03.2021

Trial locations

Investigated drugs:

Belantamab Mafodotin

Belantamab Mafodotin is a medication being studied for its effectiveness in treating patients with a condition called relapsed or refractory AL amyloidosis. This condition involves the buildup of abnormal proteins in organs and tissues, which can lead to organ damage. The medication works by targeting and destroying specific cells that contribute to this disease, potentially helping to reduce symptoms and improve patient outcomes.

Investigated diseases:

Amyloidosis

Relapsed or Refractory AL Amyloidosis – This is a condition where abnormal proteins, known as amyloids, build up in organs and tissues, causing them to function improperly. In the relapsed or refractory form, the disease has either returned after treatment or has not responded to standard therapies. The progression involves the continuous accumulation of amyloid deposits, which can lead to organ damage over time. Symptoms may vary depending on which organs are affected, commonly impacting the heart, kidneys, liver, and nervous system. Patients may experience fatigue, weight loss, swelling, and changes in organ function. The disease requires ongoing monitoring to manage symptoms and prevent further complications.

Trial ID:

2024-513075-40-00

Protocol code:

EMN27

NCT ID:

NCT04617925

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Belantamab Mafodotin for Patients with Relapsed or Refractory AL Amyloidosis

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