Study on the Effectiveness of Isatuximab, Pomalidomide, and Dexamethasone for Patients with AL Amyloidosis Not Responding Well to Previous Treatments

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What is this study about?

This clinical trial is focused on studying a condition known as AL Amyloidosis. This is a rare disease where abnormal proteins, called amyloids, build up in organs and tissues, affecting their normal function. The study will evaluate a combination treatment involving three medications: Isatuximab, Pomalidomide, and Dexamethasone. Isatuximab is a type of protein treatment known as a monoclonal antibody, which targets specific cells in the body. Pomalidomide is a medication that helps the immune system fight cancer, and Dexamethasone is a steroid that reduces inflammation and helps with the effectiveness of the other drugs.

The purpose of this study is to assess how well this combination of medications works in patients with AL Amyloidosis who have not achieved a very good response from previous treatments. Participants will receive the medications over a period of up to 12 months. The treatment involves taking Pomalidomide and Dexamethasone orally, while Isatuximab is given through an intravenous infusion, which means it is administered directly into a vein. The study will monitor the participants’ response to the treatment, focusing on improvements in their condition and any side effects experienced.

Throughout the study, participants will undergo regular assessments to track their health and the effectiveness of the treatment. These assessments will help determine if the combination of Isatuximab, Pomalidomide, and Dexamethasone can provide a better outcome for patients with AL Amyloidosis compared to previous therapies. The study aims to provide valuable information that could lead to improved treatment options for this challenging condition.

1 joining the study

Upon joining the study, the patient will begin the treatment phase. This involves taking specific medications as part of the trial protocol.

2 medication administration

The patient will receive a combination of medications: Isatuximab, Pomalidomide, and Dexamethasone.

Isatuximab is administered intravenously. This means it is given through a vein, typically in a hospital or clinic setting.

Pomalidomide is taken orally in the form of capsules. The dosage may vary, with available strengths of 1 mg, 2 mg, and 4 mg.

Dexamethasone is also taken orally as tablets. The specific dosage and schedule will be provided by the healthcare team.

3 treatment cycles

The treatment is organized into cycles. Each cycle lasts for a specific period, during which the patient will follow the medication schedule provided.

The primary goal is to assess the hematologic response after 6 cycles of treatment.

4 monitoring and assessments

Throughout the trial, regular monitoring and assessments will be conducted to evaluate the patient’s response to the treatment.

These assessments include blood tests and other evaluations to measure the effectiveness of the treatment and monitor for any side effects.

5 completion of treatment

At the end of the treatment cycles, the patient’s response will be evaluated to determine the overall effectiveness of the treatment.

The study aims to achieve a very good partial response or better in patients with AL amyloidosis.

Who Can Join the Study?

Participants must be at least 18 years old.
Male participants must agree to use birth control during the study and for at least 5 months after the last dose of the study medication. They should also not donate sperm during this time.
Female participants must not be pregnant or breastfeeding. If they can have children, they must have a negative pregnancy test before starting the study and regularly during the study. They must use two reliable birth control methods or abstain from heterosexual intercourse during the study and for at least 5 months after the last dose.
Participants must provide written consent to join the study, understanding they can leave the study at any time without affecting their future medical care.
Participants must have a confirmed diagnosis of AL amyloidosis.
Participants should have received at least one previous treatment with specific types of medications, such as an alkylating agent, PI, or anti-CD38, at least one year before starting the study. They should not have achieved a very good partial response (VGPR) or better at the time of joining the study.
Participants must have measurable disease, meaning a specific difference in certain blood proteins is greater than 50 mg/L.
Participants must have symptoms affecting organs like the heart, kidneys, liver, digestive system, or nerves.
Participants must have stopped any previous cancer treatments at least 4 weeks before starting the study or longer if required by the type of treatment.
Participants must have adequate bone marrow function, which means having enough blood cells without needing recent transfusions or growth factor support.
Participants must have adequate organ function, which includes specific levels of liver enzymes and bilirubin in the blood.
Participants must have an ECOG status of 2 or less, which is a measure of their ability to perform daily activities.

Who Cannot Join the Study?

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of allergic reactions to the study medication.
Patients who are unable to follow the study procedures.
Patients with certain types of infections that are not well controlled.
Patients with severe kidney or liver problems.
Patients who have received certain treatments that could affect 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
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble	Grenoble	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Alf Lckmlegj Tghertvxkg Inwmodhh Rbekju	Vandoeuvre Les Nancy	France
Czemkk Hkdmodkkyeb Ei Ungxyudpnqqzx Dr Lirpdvj	Limoges	France
Apazicgwbd Pjwnfykq Hoocjjbl Da Piegs	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.01.2022

Trial locations

Investigated drugs:

Isatuximab is a medication used in this trial to help treat patients with AL amyloidosis. It works by targeting specific proteins on the surface of certain cells, which can help the immune system to attack and destroy these cells. This can potentially reduce the amount of abnormal protein in the body that contributes to the disease.

Pomalidomide is another medication included in the trial. It is used to help the immune system fight against the disease by affecting the growth of certain cells. Pomalidomide can also help reduce inflammation and the production of abnormal proteins in the body.

Dexamethasone is a type of steroid used in this trial. It helps reduce inflammation and can also suppress the immune system. In the context of this trial, dexamethasone is used to enhance the effects of the other medications and help manage symptoms associated with AL amyloidosis.

Investigated diseases:

Amyloidosis

AL Amyloidosis – AL Amyloidosis is a rare disease characterized by the abnormal deposition of amyloid proteins in various tissues and organs. These proteins are produced by plasma cells in the bone marrow and can accumulate in the heart, kidneys, liver, and other organs, leading to organ dysfunction. The disease progresses as more amyloid proteins are deposited, causing the affected organs to work less efficiently. Symptoms can vary widely depending on which organs are involved, but may include fatigue, weight loss, swelling, and shortness of breath. Over time, the accumulation of amyloid proteins can lead to significant organ damage. The progression of the disease is often monitored through various clinical assessments and laboratory tests.

Trial ID:

2024-513887-25-00

Protocol code:

IFM 2020-01

NCT ID:

NCT05066607

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Isatuximab, Pomalidomide, and Dexamethasone for Patients with AL Amyloidosis Not Responding Well to Previous Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?