Dunkerque

Researchers are evaluating the use of Synolis VA 80160, a device containing hyaluronic acid and sorbitol, in adults with hip osteoarthritis. This study aims to assess the effectiveness and safety of this treatment over a 6-month period in patients experiencing symptoms related to this condition who have not responded well to standard pain relief treatments. The study is conducted independently across multiple centers. Participants will receive a single guided injection of Synolis VA 80160 directly into the affected hip joint. The study monitors changes in hip function and pain using the Oxford Hip Score at various points including 3 and 6 months after injection. Additional evaluations include patient self-assessments of symptom evolution and tracking whether participants require hip prosthesis placement within 6 months. During the study, participants will undergo assessments at baseline and follow-up visits where their hip function and symptoms are measured using standard questionnaires. The main outcome is the evolution of the Oxford Hip Score after 6 months. Researchers will also monitor safety and any need for hip replacement surgery. Participants will be involved for the full 6-month study duration, with data collected to understand both short-term and longer-term effects of the treatment.

Multiple myeloma MM is a cancer affecting plasma cells in the blood, often found in bones and bone marrow. It can cause bone pain, fractures, infections, weaker bones, and kidney failure. Researchers are studying the investigational drug Etentamig to understand its side effects, impact on disease activity, and how it behaves in the body for adults with MM. This study is conducted in two phases, phase 2 and phase 3, involving about 660 adult participants worldwide who have newly diagnosed MM and are not eligible for transplant. In phase 2, participants receive one of three doses of Etentamig combined with daratumumab in phase 3, participants receive the recommended phase 3 dose RP3D of Etentamig with daratumumab or a combination of daratumumab, lenalidomide, and dexamethasone DRd. Etentamig is given as intravenous infusions, daratumumab as subcutaneous injections, lenalidomide as capsules, and dexamethasone as oral tablets or intravenous injections. The study lasts approximately 16 years, with treatments continuing until the recommended dose is reached or as part of the study duration. Participants will attend regular hospital or clinic visits where their response to treatment will be monitored through medical exams, blood tests, side effect checks, and questionnaires. Researchers will measure outcomes like adverse events, disease activity changes, minimal residual disease rates, progression-free survival, and overall survival over up to 16 years. The study aims to assess both safety and disease control with ongoing monitoring and evaluations throughout the long study period.

This research aims to evaluate the efficacy and safety of belantamab mafodotin given with standard cancer treatments in adults with relapsed or refractory multiple myeloma, a type of blood cancer that has returned or is not responding to prior treatments. The study focuses on whether giving belantamab mafodotin less frequently can still control the cancer while reducing side effects, especially those affecting the eyes. It is a phase 2, open-label study sponsored by GlaxoSmithKline. Participants will receive belantamab mafodotin combined with one of three standard treatment regimens pomalidomide and dexamethasone bortezomib and dexamethasone or carfilzomib and dexamethasone. The study uses an extended dosing schedule to assess if less frequent dosing maintains effectiveness. The treatment continues as per the assigned combination, with no randomization, in multiple centers. During the study, participants will be regularly assessed for response to treatment, including overall response rate and complete response rate, up to about 52 months. Safety will be monitored by recording side effects and eye health through ophthalmic exams. Participants will undergo laboratory tests and clinical evaluations throughout the study. The research will also track how well patient-reported eye symptoms match clinical findings, with the total study duration extending up to approximately four years.

Researchers are evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Pemphigus diseases are serious, chronic autoimmune conditions that cause blistering due to the immune system attacking certain skin proteins. The two main types studied here are pemphigus vulgaris and pemphigus foliaceus. Researchers are evaluating a new personalized maintenance therapy involving rituximab infusions guided by antibody levels to see if this approach can better prevent disease relapses compared to the standard treatment. This is a phase 4 randomized study conducted by the University Hospital, Rouen, building on previous rituximab trials that led to regulatory approvals. Participants in the trial will receive initial treatment with rituximab and oral prednisone following French guidelines, with rituximab given at Day 1, Day 14, Month 12, and Month 18. One group will receive this standard regimen, while the experimental group will have their treatment adapted based on anti-desmoglein antibody levels. Additional rituximab infusions may be given at Month 6 or later if antibody levels remain high or increase, with up to two extra infusions per year allowed during the study. During the study, participants will be regularly monitored through blood tests for antibody levels and blood cells every three months for up to 7.5 years. Researchers will assess the number of disease relapses, time to relapse, duration of remission, quality of life, and rituximab exposure. The study will also track the total dose of rituximab and record safety outcomes. This long follow-up aims to understand if personalized maintenance with rituximab can reduce relapses and the need for corticosteroid treatment.

Researchers are evaluating whether adding local consolidative radiotherapy to the standard treatment improves overall survival in patients with metastatic urothelial bladder cancer. This study focuses on patients who have no disease progression and have no more than three remaining distant metastatic lesions after completing first-line systemic therapy. It is a Phase II, randomized, open-label study conducted at multiple centers. Participants will be randomly assigned either to receive standard care alone or to receive consolidative radiotherapy targeting the pelvis andor metastatic sites in addition to standard care. Some patients may have had a previous bladder tumor resection. The radiotherapy is given after the initial systemic treatment phase, which includes chemotherapy andor immunotherapy. The study follows patients for four years from the time of randomization. During the study, patients will have regular assessments including imaging scans to check disease status, toxicity evaluations according to national criteria, and quality of life questionnaires using the EORTC QLQ-C-30 tool. Researchers will monitor overall survival and progression-free survival over four years. Patients must be able to participate and agree to follow the study procedures, and safety is closely observed throughout the trial.

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimers disease at early to moderate stages, characterized by a Mini-Mental State Examination MMSE score between 16 and 24. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the 30-week impact of caffeine treatment on cognition. The study addresses the potential benefits and risks of caffeine, considering its complex effects on the central nervous system, including possible anxiety and insomnia at high doses, which may be more pronounced in Alzheimers patients. Participants begin with a 3-week dose escalation period, followed by a 27-week treatment phase. The caffeine group receives capsules starting at 100 mg, titrated up by 100 mg increments to a target dose of 400 mg per day divided into two doses, while the placebo group undergoes a similar regimen with placebo capsules. After the treatment period, caffeine is tapered off using the same negative titration. Both groups follow a low caffeine diet before and during the study. During the study, participants undergo regular assessments of cognitive function using the Neuropsychological Test Battery NTB scores at 30 weeks and six weeks after treatment ends to observe any lasting effects. Additional evaluations include MMSE scores, attention tests, sleepiness scales, daily living activities, quality of life, caregiver burden, clinical global impression, and safety monitoring of heart rate and blood pressure. Blood samples will measure caffeine and its derivatives. The study involves caregivers living with the patient and lasts for at least 36 weeks from randomization.

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

This research aims to describe how patients aged 18 years or older with moderate to severe atopic dermatitis AD are managed with systemic therapy. It focuses on patients eligible for or currently receiving systemic treatments, following their care under real-world conditions. The study involves French dermatologists experienced in AD management, whether practicing in hospitals or private offices. Treatment decisions are made independently by the physicians and not influenced by the study enrollment. Participants will receive systemic treatments for AD prescribed by their doctors as part of routine care, with no investigational drugs involved. Information will be collected during regular visits according to usual clinical practice. The study will follow patients for one year, tracking their treatments and management without altering standard care. During the year, patients will be assessed at baseline, 6 months, and 12 months. Researchers will collect data on previous and current treatments, treatment adherence, changes in disease severity, itch, sleep disturbance, skin pain, quality of life, psychological health, work absences, and hospitalizations related to AD. This comprehensive follow-up aims to better understand how systemic therapies are used and their impact on patients in everyday clinical settings.

Researchers are analyzing the real-world experience of patients treated with Glofitamab for relapsed or refractory large B-cell lymphoma DLBCL. This observational study focuses on patients who participated in the French Expanded Access Programme EAP, with more than 300 treated patients and a median follow-up expected to exceed nine months. The study particularly aims to confirm the response rates of Glofitamab in patients who have previously received CAR-T therapy and to determine the best timing to start the treatment. The study includes patients who received at least one infusion of Glofitamab following pretreatment with Obinutuzumab as part of the Early Phase Access program. The treatment details are collected retrospectively from patients enrolled before November 1, 2024. The primary outcome being assessed is the best complete response rate during treatment, based on investigator evaluation using Lugano 2014 criteria at six months. Participants data will be reviewed to measure treatment effectiveness and safety, including complete metabolic response rates, progression-free survival, event-free survival, overall survival, rates of immune-related side effects like neurotoxicity and cytokine release syndrome, ICU admissions, and hospitalization events over six months. This analysis helps to better understand Glofitamabs performance in a large real-world patient group, with continued monitoring of outcomes and adverse events during the follow-up period.