Primary amyloidosis – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Wed, 24 Jun 2026 04:15:17 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Primary amyloidosis – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on Safe Skin Test Concentrations for Biotherapy Allergies in Patients with Cancer Using Atezolizumab, Daratumumab, and Nivolumab https://clinicaltrials.eu/trial/study-on-safe-skin-test-concentrations-for-biotherapy-allergies-in-patients-with-cancer-using-atezolizumab-daratumumab-and-nivolumab/ Wed, 29 Apr 2026 15:05:16 +0000 https://clinicaltrials.eu/trial/study-on-safe-skin-test-concentrations-for-biotherapy-allergies-in-patients-with-cancer-using-atezolizumab-daratumumab-and-nivolumab/ This clinical trial is focused on evaluating skin tests for allergies related to certain biotherapy treatments. The diseases being studied include Chronic Lymphocytic Leukemia, AL Amyloidosis, Esophageal Squamous Cell Carcinoma, Myeloma, Cholangiocarcinoma, Hodgkin Lymphoma, Non-Small Cell Lung Carcinoma, Colorectal Adenocarcinoma with deficient mismatch repair, Small Cell Lung Carcinoma, Follicular Lymphoma, Melanoma, Hepatocellular Carcinoma, Gastric Cardia Cancer, Locally Advanced Cutaneous Squamous Cell Carcinoma, and Pleural Mesothelioma. The treatments being tested include Atezolizumab, Nivolumab, Obinutuzumab, Durvalumab, Pembrolizumab, Daratumumab, and Cemiplimab. These treatments are types of biotherapy, which use substances made from living organisms to treat diseases.

The purpose of the study is to find out the highest concentration of these biotherapy drugs that can be used in skin tests without causing irritation in patients who are not allergic. The study will involve skin tests, such as prick tests and intradermal tests, to check for any allergic reactions. Patients who have been treated with these biotherapies and have not shown any allergic reactions will be part of the study. The study will monitor for any immediate or delayed skin reactions after the tests.

Throughout the study, patients will be contacted to confirm if there are any delayed reactions, which might occur up to a week after the skin tests. If a reaction is suspected, a photograph or video consultation with an allergist may be used to confirm it. The study aims to ensure that the skin tests are safe and do not cause unnecessary irritation to patients undergoing biotherapy treatments.

]]> Study of Teclistamab for Patients with Previously Treated AL Amyloidosis https://clinicaltrials.eu/trial/study-of-teclistamab-for-patients-with-previously-treated-al-amyloidosis/ Wed, 29 Apr 2026 15:04:37 +0000 https://clinicaltrials.eu/trial/study-of-teclistamab-for-patients-with-previously-treated-al-amyloidosis/ This clinical trial is focused on studying a condition known as Immunoglobulin Light-Chain (AL) Amyloidosis. This is a disease where abnormal proteins, called amyloids, build up in organs and tissues, affecting their normal function. The trial will use a treatment called teclistamab, which is a solution for injection. Teclistamab is a type of medication known as a BiTE, or bispecific T-cell engager, which is designed to help the immune system target and destroy abnormal cells.

The purpose of the study is to evaluate how well teclistamab works in patients who have previously been treated for AL amyloidosis. Participants will receive teclistamab injections under the skin over a period of time. The study will monitor the response of the disease to the treatment after three cycles, which are periods of treatment followed by rest. The study will also look at how long the response lasts, how the organs affected by the disease respond, and the overall safety and tolerability of the treatment.

Throughout the study, participants will be regularly assessed to see how their condition is responding to the treatment. This includes checking for any changes in their health and any side effects they might experience. The study aims to provide valuable information on the effectiveness and safety of teclistamab for people with AL amyloidosis, potentially leading to better treatment options in the future.

]]> Study on the Safety and Effectiveness of Sargramostim with Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Untreated Light Chain Amyloidosis Patients https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-sargramostim-with-daratumumab-cyclophosphamide-bortezomib-and-dexamethasone-in-untreated-light-chain-amyloidosis-patients/ Wed, 29 Apr 2026 15:03:13 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-sargramostim-with-daratumumab-cyclophosphamide-bortezomib-and-dexamethasone-in-untreated-light-chain-amyloidosis-patients/ This clinical trial is focused on studying a condition called Light Chain Amyloidosis, which is a rare disease where abnormal proteins called amyloids build up in organs like the heart and kidneys, leading to their failure. The study will use a combination of treatments known as D-VCd Therapy, which includes the medications Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone. Additionally, a substance called Sargramostim will be used. Sargramostim is known to help the body produce more white blood cells and may assist in breaking down amyloid deposits.

The purpose of this study is to evaluate how effective and safe this combination of treatments is for patients who have not yet received treatment for Light Chain Amyloidosis. Participants in the study will receive these medications and be monitored for their response to the treatment and any side effects they may experience. The study aims to see if the treatment can lead to a complete response in the blood and improve the function of affected organs.

The study will take place over a period of time, during which participants will receive the treatment and undergo regular check-ups to assess their health and the progress of the disease. The goal is to determine if this combination of treatments can provide a better outcome for patients with Light Chain Amyloidosis by reducing the amyloid deposits and improving organ function.

]]> Study on the Effectiveness and Safety of CAEL-101 with Drug Combination for Patients with Advanced AL Amyloidosis https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-cael-101-with-drug-combination-for-patients-with-advanced-al-amyloidosis/ Wed, 29 Apr 2026 14:29:33 +0000 https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-cael-101-with-drug-combination-for-patients-with-advanced-al-amyloidosis/ This clinical trial is focused on studying a condition called AL amyloidosis, specifically in patients with a severe form known as Stage IIIb cardiac AL amyloidosis. This disease involves the buildup of abnormal proteins in the heart, which can lead to heart problems. The study is testing a new treatment called CAEL-101, also known by its code name anselamimab. This treatment is being compared to a placebo, which is a substance with no active medication, to see if it can improve the survival of patients who have not received any previous treatment for this condition.

Participants in the study will receive either the new treatment or a placebo, along with standard treatments for a related condition called plasma cell dyscrasia. The standard treatments include medications such as cyclophosphamide, bortezomib, and dexamethasone. These medications are commonly used to treat disorders involving abnormal plasma cells, which are a type of white blood cell. The study aims to determine if the combination of CAEL-101 and these standard treatments can help patients live longer and improve their quality of life.

The study will be conducted over a period of time, during which participants will receive their assigned treatments and be monitored for any changes in their health. The main goal is to assess the time it takes for any cause of death to occur from the start of the study. Additionally, the study will look at other health measures, such as heart function and physical activity levels, to evaluate the overall effectiveness and safety of the new treatment. Participants will be closely observed to ensure their safety throughout the study.

]]> Study on the Safety and Effectiveness of Linvoseltamab, Sarilumab, and Dexamethasone in Adults with Relapsed or Refractory AL Amyloidosis https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-linvoseltamab-sarilumab-and-dexamethasone-in-adults-with-relapsed-or-refractory-al-amyloidosis/ Wed, 29 Apr 2026 14:28:52 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-linvoseltamab-sarilumab-and-dexamethasone-in-adults-with-relapsed-or-refractory-al-amyloidosis/ 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.

]]> Study on the Effectiveness and Safety of CAEL-101 with Plasma Cell Dyscrasia Treatment in Patients with Stage IIIa AL Amyloidosis https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-cael-101-with-plasma-cell-dyscrasia-treatment-in-patients-with-stage-iiia-al-amyloidosis/ Wed, 29 Apr 2026 14:28:26 +0000 https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-cael-101-with-plasma-cell-dyscrasia-treatment-in-patients-with-stage-iiia-al-amyloidosis/ This clinical trial is focused on studying a condition called AL amyloidosis, specifically in patients with a severe form known as stage IIIa cardiac AL amyloidosis. This disease involves the buildup of abnormal proteins in organs and tissues, which can affect the heart. The study is testing a new treatment called CAEL-101, which is given as a solution through an intravenous infusion. The trial will compare the effects of CAEL-101 combined with standard treatment for a related condition called plasma cell dyscrasia against a placebo combined with the same standard treatment.

The purpose of the study is to see if CAEL-101 can help improve the survival of patients who have not yet received treatment for their condition. The study will also look at how safe and tolerable CAEL-101 is when used with the standard treatment. Participants will receive either the new treatment or a placebo, along with their regular therapy, and will be monitored over time to assess their health and any changes in their condition.

Throughout the study, participants will undergo various health checks, including monitoring of vital signs and heart function, to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into the potential benefits of CAEL-101 for patients with this challenging disease.

]]> Study on Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone for Patients with Newly Diagnosed Systemic AL Amyloidosis https://clinicaltrials.eu/trial/study-on-daratumumab-cyclophosphamide-bortezomib-and-dexamethasone-for-patients-with-newly-diagnosed-systemic-al-amyloidosis/ Wed, 29 Apr 2026 14:28:10 +0000 https://clinicaltrials.eu/trial/study-on-daratumumab-cyclophosphamide-bortezomib-and-dexamethasone-for-patients-with-newly-diagnosed-systemic-al-amyloidosis/ 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.

]]> Study of Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone for Patients with Newly Diagnosed AL Amyloidosis with Heart Involvement https://clinicaltrials.eu/trial/study-of-daratumumab-bortezomib-cyclophosphamide-and-dexamethasone-for-patients-with-newly-diagnosed-al-amyloidosis-with-heart-involvement/ Wed, 29 Apr 2026 14:25:55 +0000 https://clinicaltrials.eu/trial/study-of-daratumumab-bortezomib-cyclophosphamide-and-dexamethasone-for-patients-with-newly-diagnosed-al-amyloidosis-with-heart-involvement/ 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.

]]> Study on Birtamimab and Bortezomib for Patients with Advanced Light Chain Amyloidosis https://clinicaltrials.eu/trial/study-on-birtamimab-and-bortezomib-for-patients-with-advanced-light-chain-amyloidosis/ Wed, 29 Apr 2026 14:22:29 +0000 https://clinicaltrials.eu/trial/study-on-birtamimab-and-bortezomib-for-patients-with-advanced-light-chain-amyloidosis/ This clinical trial is focused on studying a condition known as Light Chain (AL) Amyloidosis, which is a rare disease where abnormal proteins build up in organs and tissues, affecting their normal function. The study will evaluate the effectiveness and safety of a treatment involving a medication called Birtamimab, which is a type of protein designed to target and neutralize harmful substances in the body. Birtamimab will be used in combination with the standard treatment for AL amyloidosis, which includes medications like Bortezomib, a drug that helps to slow down or stop the growth of abnormal cells. The study will also involve a comparison with a placebo, which is an inactive substance used to assess the treatment’s true effects.

The purpose of the study is to determine how well Birtamimab, when added to the standard treatment, works in patients with a severe form of AL amyloidosis, known as Mayo Stage IV. Participants will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will be conducted in two phases: a double-blind phase, where neither the participants nor the researchers know who is receiving the actual treatment or the placebo, and an open-label extension phase, where all participants will receive Birtamimab to evaluate its long-term safety.

Throughout the study, researchers will monitor the participants’ health and track important outcomes, such as the time it takes for any cause of death to occur during the double-blind phase. Additionally, they will assess changes in physical abilities and quality of life over a period of nine months. This trial aims to provide valuable insights into the potential benefits of Birtamimab for patients with AL amyloidosis, offering hope for improved treatment options in the future.

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