Ongoing Clinical Trials for Plasma Cell Leukaemia
There are currently 3 clinical trials investigating new treatments for plasma cell leukaemia, a rare and aggressive form of blood cancer. These trials are testing different combinations of medications and innovative therapies, including targeted antibodies and genetically modified immune cell treatments. The studies are taking place in Greece, Spain, and France, offering patients with this challenging condition access to potentially promising treatment approaches.
Clinical trial locations
- France
- Greece
- Spain
Study on the Effectiveness and Safety of Bortezomib and Daratumumab for Patients with Primary Plasma Cell Leukemia
This trial, taking place in Greece, is investigating a treatment combination for patients who have not yet received any treatment for their condition. The study follows a structured approach with three distinct phases: induction, consolidation, and maintenance.
Who can participate: The trial is open to adults between 18 and 80 years old who have been newly diagnosed with primary plasma cell leukemia and meet specific disease criteria. Participants must have measurable disease levels in their blood or urine and be eligible for high-dose therapy, with or without stem cell transplantation. Adequate bone marrow, liver, and kidney function is required, along with reasonable performance status that allows for daily activities.
Who cannot participate: Patients with other types of cancer, recent heart problems within the past 6 months, uncontrolled high blood pressure, severe liver or kidney disease, active infections requiring treatment, or known allergies to the study drugs are excluded. Pregnant or breastfeeding women and those with a history of drug or alcohol abuse in the past year cannot participate.
What the trial involves: The study evaluates how well a treatment plan combining bortezomib and daratumumab works. Bortezomib blocks certain proteins in cancer cells to slow their growth, while daratumumab helps the immune system identify and destroy cancer cells by targeting specific proteins on their surface. The treatment begins with alternating bortezomib-based regimens combined with daratumumab, along with other medications including doxorubicin, dexamethasone, and cyclophosphamide. After the initial phase, patients receive consolidation treatment, followed by maintenance therapy using daratumumab alone. The medications are administered through various methods including injections under the skin, intravenous infusions, and oral tablets.
Study on the Safety and Effectiveness of ARI0002h and Drug Combination for Newly Diagnosed Primary Plasma Cell Leukemia Patients
This Spanish trial is testing an innovative approach using genetically modified immune cells to fight the disease. The treatment, known as CAR-T cell therapy, represents a cutting-edge method of harnessing the body’s own immune system.
Who can participate: Adults between 18 and 75 years old who have been newly diagnosed with primary plasma cell leukemia are eligible. Participants must have at least 5% plasma cells in their blood and measurable disease confirmed by specific blood or urine protein tests. They must have an ECOG Performance Status of 0 to 1, meaning they are fully active or restricted only in physically demanding activities but able to carry out light work. Good venous access suitable for the cell collection procedure is required, along with a life expectancy of more than 3 months.
Who cannot participate: The trial excludes patients with other types of cancer, those who have received experimental treatments for their condition, individuals with severe heart problems or recent heart attacks, and those with active infections requiring treatment. Patients with severe allergic reactions to study components, pregnant or breastfeeding women, those with uncontrolled high blood pressure or diabetes, and individuals with recent major surgery within 4 weeks are not eligible.
What the trial involves: The study evaluates ARI0002h, also known as Cesnicabtagene autoleucel, a CAR-T cell therapy that uses the patient’s own immune cells. These cells are collected, genetically modified in a laboratory to better recognize and attack cancer cells, and then returned to the patient through an infusion. The modified cells target a protein called BCMA found on cancer cells. Before receiving the main treatment, patients undergo preparation with lenalidomide, cyclophosphamide, and fludarabine. Additional supportive medications like paracetamol and tocilizumab may be used to manage side effects. The trial includes careful monitoring for potential reactions including cytokine release syndrome and neurological symptoms, with follow-up extending up to 24 months to assess treatment response and quality of life.
Study on Daratumumab, Lenalidomide, and Dexamethasone for Patients with Primary Plasma Cell Leukemia
This French trial examines a combination of medications along with stem cell transplantation for eligible patients, with the study expected to continue until 2028.
Who can participate: The trial is designed for patients aged 18 to 69 years old with primary plasma cell leukemia, defined as having at least 5% circulating plasma cells in the blood. Participants must be eligible for high-dose Melphalan therapy with autologous stem cell transplantation. An ECOG performance status of 0, 1, or 2 is required, indicating they can perform daily activities with varying levels of restriction. Adequate kidney function with creatinine clearance of at least 20 mL/min is necessary, along with liver enzyme levels no more than 3 times the normal limit and total bilirubin no more than 2 times normal. Female participants of childbearing potential must agree to use two effective methods of birth control throughout the study and for 90 days after treatment completion.
Who cannot participate: The trial has specific criteria ensuring participant safety and study integrity, though detailed exclusion criteria focus on ensuring adequate organ function and appropriate disease characteristics.
What the trial involves: This study combines several treatment approaches. The induction phase uses lenalidomide (Revlimid) in capsule form, daratumumab (DARZALEX) administered as a subcutaneous injection, dexamethasone given both intravenously and orally, and bortezomib administered subcutaneously. Daratumumab is a monoclonal antibody that attaches to specific proteins on cancer cells, helping the immune system destroy them. Following induction therapy, eligible patients undergo stem cell transplantation using high-dose Melphalan chemotherapy to prepare the body. The trial monitors various outcomes including response rates, progression-free survival, overall survival, and quality of life using standardized questionnaires. The study also evaluates treatment effectiveness based on specific genetic changes in cancer cells.
Summary
The three clinical trials currently available for plasma cell leukaemia demonstrate diverse therapeutic approaches to this rare and aggressive blood cancer. Each trial is conducted in a different European country—Greece, Spain, and France—providing geographical diversity in access to experimental treatments.
A notable observation is that two of the three trials utilize daratumumab, a monoclonal antibody targeting cancer cells, highlighting its importance as an investigational treatment for this condition. The Greek and French trials both incorporate daratumumab in combination with other established cancer medications, while the Spanish trial takes an innovative approach with CAR-T cell therapy, representing one of the most advanced forms of immunotherapy currently under investigation.
All three studies focus exclusively on newly diagnosed patients who have not received prior treatment, suggesting researchers are investigating first-line treatment options that might improve outcomes from the earliest stages of diagnosis. The trials vary in their approach to treatment intensity, with two studies including pathways to stem cell transplantation for eligible patients, while the Spanish trial focuses solely on the CAR-T cell approach without transplantation.
The age ranges differ slightly across trials, with the French study having the most restrictive upper age limit of 69 years, while the Greek trial accepts patients up to 80 years old. This variation reflects different approaches to balancing treatment intensity with patient safety considerations.
