RecruitingRare disease

Study on the Safety and Effectiveness of Linvoseltamab, Sarilumab, and Dexamethasone in Adults with Relapsed or Refractory AL Amyloidosis

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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 known as Systemic Light Chain Amyloidosis, which is a disease where abnormal proteins build up in organs and tissues, causing them to not work properly. The study is testing a new treatment called Linvoseltamab, which is being evaluated for its safety and effectiveness in patients whose disease has returned or has not responded to previous treatments. The purpose of the study is to determine the best dose of Linvoseltamab and to see how well it works in achieving a complete response in the blood, which means the disease is no longer detectable.

Participants in the study will receive Linvoseltamab as a solution for infusion, which means it will be administered directly into the bloodstream through a vein. The study will be conducted in two phases. In the first phase, the focus will be on assessing the safety and tolerability of Linvoseltamab, while the second phase will evaluate its effectiveness in treating the disease. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Linvoseltamab. Throughout the study, participants will be closely monitored for any side effects or changes in their condition.

The study aims to gather information on how Linvoseltamab affects the disease and its progression, as well as any potential side effects. This information will help determine if Linvoseltamab can be a safe and effective treatment option for people with relapsed or refractory Systemic Light Chain Amyloidosis. The trial is expected to continue for several years to ensure comprehensive data collection and analysis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of relapsed or refractory systemic light chain amyloidosis and ensuring that previous treatments have been administered.
The assessment also checks for adequate liver, blood, kidney, and heart function, and evaluates the performance score to ensure it is 2 or less.
Step 2
Treatment initiation
The treatment phase begins with the administration of linvoseltamab as a solution for infusion. The dosage and frequency are determined based on the initial assessment results.
Additional medications may be administered to manage side effects, including dexamethasone sodium phosphate and diphenhydramine hydrochloride.
Step 3
Monitoring and adjustments
Regular monitoring is conducted to assess the body's response to the treatment. This includes blood tests and other evaluations to measure the effectiveness and safety of the medication.
Adjustments to the dosage of linvoseltamab or other medications may be made based on the results of these assessments.
Step 4
Follow-up evaluations
Follow-up evaluations are scheduled to determine the achievement of a complete response or other levels of response to the treatment.
These evaluations help in understanding the duration of the response and any progression of the disease.
Step 5
End of treatment
The treatment phase concludes based on the study's timeline or if the desired response is achieved.
Final assessments are conducted to evaluate the overall effectiveness and any long-term effects of the treatment.

Who can join the trial?

9 criteria

Must have a confirmed diagnosis of **AL amyloidosis**. This is a condition where abnormal proteins build up in tissues and organs.
Must have a **measurable disease**. This means that the disease can be tracked by measuring certain proteins in the blood.
Must have been treated with at least one but no more than four previous therapies. This can include a procedure called **autologous stem cell transplant**, where a patient's own stem cells are used to replace damaged cells.
Must need further treatment as determined by the doctor in charge of the study.
Must have a **N-terminal pro b-type natriuretic peptide (NT-proBNP)** level of 8500 ng/L or less during screening. This is a blood test that helps assess heart function.
Must have adequate liver, blood, kidney, and heart function as described in the study details.
Must have an **Eastern Cooperative Oncology Group (ECOG) performance score** of 2 or less. This score measures how well a person can perform daily activities.
Must be within the age range specified by the study, which includes adults.
Both male and female participants are eligible.

Who cannot join the trial?

4 criteria

Patients who have a different condition than Relapsed or Refractory Systemic Light Chain Amyloidosis cannot participate. This condition involves abnormal proteins affecting organs.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
Patients who do not meet the specific health requirements set by the study cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Alexandra Hospital
Athens, Greece
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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain

Trial locations

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Investigated drugs

Linvoseltamab is a medication being studied for its safety and effectiveness in treating patients with a condition called systemic light chain amyloidosis, which has returned or not responded to previous treatments. The goal of using linvoseltamab in this trial is to find the best dose for future studies and to see how well it helps in achieving a complete response in the blood.

What is already known about the treatment

Linvoseltamab – Linvoseltamab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory systemic light chain amyloidosis, a condition where abnormal proteins build up in organs. The medication works by targeting specific proteins involved in the disease process, aiming to reduce their harmful effects. Linvoseltamab is classified as a monoclonal antibody, a type of drug designed to interact with specific molecules in the body to help manage disease symptoms.

Investigated diseases

Systemic Light Chain Amyloidosis – This is a rare disease where abnormal proteins, known as light chains, are produced by plasma cells and deposit in various tissues and organs. These deposits can cause the affected organs to function improperly. The disease often progresses by affecting the heart, kidneys, liver, and nervous system, leading to a range of symptoms depending on the organs involved. Over time, the accumulation of amyloid proteins can lead to organ damage. The condition is typically characterized by its relapsing or refractory nature, meaning it can return or resist treatment. The progression and impact of the disease vary widely among individuals.