Boussu

Researchers are evaluating treatments for participants with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. This Phase 3 study compares if the combination of belantamab mafodotin, lenalidomide, and dexamethasone (BRd) can extend progression-free survival or increase the number of participants achieving minimal residual disease negative status compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd). Participants will receive either BRd or DRd treatment. Belantamab mafodotin, lenalidomide, and dexamethasone will be administered in the BRd group, while daratumumab, lenalidomide, and dexamethasone will be given in the DRd group. The study will monitor participants over approximately 7 years to assess long-term outcomes. During the study, participants will undergo assessments to measure progression-free survival and minimal residual disease status. Researchers will collect clinical data, laboratory tests, and safety information throughout the treatment and follow-up periods. The total duration of participation may last up to about 7 years to evaluate long-term effects and outcomes of the treatments.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating and comparing standard neoadjuvant treatment options for older patients, aged 70 years and above, who have high-risk stage II or stage III rectal cancer. This multicenter, open-label, randomized pragmatic clinical trial aims to study the effectiveness and safety of conventional neoadjuvant therapy versus total neoadjuvant therapy in this patient group. Participants will be randomly assigned to one of two treatment groups. The conventional arm includes either short-course radiotherapy (5 daily fractions of 5 Gy) followed by surgery or watch & wait, with optional adjuvant chemotherapy, or long-course chemoradiotherapy (25-28 fractions of 1.8-2.0 Gy combined with chemotherapy) followed by surgery or watch & wait, and optional adjuvant chemotherapy. The total neoadjuvant therapy arm involves different regimens at the investigator's discretion, including RAPIDO, RAPIDO light, and OPRA regimens, combining radiotherapy, chemotherapy, and surgery or watch & wait. Each regimen varies by radiation dose, chemotherapy duration, and sequence. During the study, participants will undergo treatments as per their assigned group. Researchers will monitor overall survival, progression-free survival, peripheral sensory neuropathy, and grade 3 or higher toxicities at 3 years after randomization. The study involves assessments of clinical response and adherence to treatment protocols. Safety and efficacy will be tracked throughout the study period to evaluate long-term outcomes for these older patients with locally advanced rectal cancer.

Researchers are evaluating a medicine called elranatamab for the treatment of multiple myeloma (MM), a type of cancer. This study focuses on people aged 18 or older who have MM that has returned or not responded to previous treatments, including prior use of an anti-CD38 antibody and lenalidomide. The goal is to compare elranatamab to other common combination therapies that include 2 to 3 different MM medicines. This is a Phase 3 study to learn about the safety and effectiveness of elranatamab compared to these other treatments. Participants will be randomly assigned to receive either elranatamab or a combination therapy selected by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, which may later reduce in frequency. The combination therapy options include medicines taken by mouth and given either as shots under the skin or through a needle in the vein at the clinic. The combination medicines used may be elotuzumab, pomalidomide, dexamethasone, bortezomib, or carfilzomib, depending on the chosen treatment plan. Participants may continue their assigned treatment until their MM stops responding. During the study, participants will visit the clinic regularly for monitoring and evaluation. Researchers will track how well the treatments work by measuring progression-free survival and will watch for any side effects or safety concerns. Follow-up will continue after treatment ends through phone calls or visits. The study may last up to about 5 years to fully assess the outcomes of the treatments.

Muscle wasting and edema are common complications in critically ill patients, particularly those requiring intensive care. The rapid decrease in muscle mass and strength, known as ICU-acquired weakness, affects both peripheral and respiratory muscles, reducing patients' functional capacity in both the short and long term. Early interventions like physical therapy and mobilization have been shown to improve patient outcomes, but there is a need for accurate monitoring of muscle mass and fluid balance during the ICU stay to guide treatment. This study leverages two complementary measurement techniques: ultrasound and bioelectrical impedance analysis (BIA). Ultrasound allows for the rapid and non-invasive assessment of muscle thickness and subcutaneous tissues. Previous studies have demonstrated that patients in the ICU can lose around 2% of their rectus femoris muscle thickness per day during the first week of their ICU stay. Ultrasound can also assess the structural changes in muscle tissue, such as alterations in echogenicity, that occur due to the inflammatory state of critically ill patients. However, patients undergoing aggressive fluid resuscitation to counteract shock and hypotension may experience fluid overload, which can distort early ultrasound measurements by causing tissue edema. Bioelectrical impedance analysis (BIA), on the other hand, is a widely used method for evaluating body composition, particularly in terms of fat-free mass, fat mass, and fluid compartments. In the ICU, BIA is highly sensitive to changes in fluid balance, providing estimates of extracellular and intracellular water. This makes BIA particularly useful for tracking fluid shifts and edema development over time in critically ill patients. The primary objective of this study is to explore the correlation between daily fluid balance and the changes in muscle thickness and subcutaneous tissue, as measured by ultrasound, and to assess the utility of BIA in evaluating fluid status and estimating the presence of edema. Specifically, the study will address two main research questions: (1) Is there a correlation between fluid balance and muscle thickness or subcutaneous tissue variation during the ICU stay? (2) Can BIA accurately reflect positive fluid balance and help estimate the extent of tissue edema? The study will also include an exploratory analysis at ICU discharge to determine whether there is a link between the presence of edema and patients' muscle strength. Muscle strength will be assessed using both the MRC-sum score (0-60) and handgrip strength with a Jamar dynamometer. Previous studies have shown that ICU-acquired weakness is associated with poorer long-term outcomes, and this study will explore whether edema contributes to this weakness. Patients will be recruited according to predefined inclusion and exclusion criteria. Upon obtaining consent from the patient or their legal representative, baseline clinical data (age, sex, BMI, reason for ICU admission, comorbidities, and severity scores such as APACHE-2 and SOFA) will be collected. Daily data will include vital signs, ventilatory settings, fluid balance, body weight, and medication details. Ultrasound and BIA measurements will be taken daily, with the patient positioned in a standardized way (supine position with a 30° incline). The ultrasound measurements will focus on the rectus femoris, tibialis anterior, and biceps brachii muscles, along with key subcutaneous tissues prone to fluid accumulation. BIA measurements will estimate total body water, extracellular water (ECW), intracellular water (ICW), muscle mass, and fat mass. At ICU discharge, handgrip strength and MRC-sum score measurements will be performed to assess functional recovery and muscle strength. This study will provide valuable insights into how fluid management and edema contribute to muscle wasting and weakness in critically ill patients, informing future therapeutic strategies.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer affecting white blood cells, and it is the most common form of non-Hodgkin lymphoma. Follicular lymphoma (FL) is a slower-growing type of this lymphoma. This study aims to evaluate the real-world effectiveness of the investigational drug epcoritamab in adult patients with advanced DLBCL and FL. Around 700 participants will be enrolled across approximately 80 sites in 12 to 20 countries worldwide. Participants will receive epcoritamab as prescribed by their doctors according to the approved treatment guidelines in their country. The study does not add any extra treatments or procedures beyond what their doctors recommend. Participants will be followed for up to about 3 years to observe their responses to the treatment. During the study, participants will attend regular visits at hospitals or clinics as part of their standard care routine. Researchers will track the percentage of participants who achieve an overall response to treatment over the study period. There is no expected additional burden for participants beyond their usual clinical visits and treatments.

Researchers are evaluating the clinical efficacy and safety of the anti-BCMA/CD3 bispecific antibody teclistamab (Tecvayli4) in patients with relapsed and refractory multiple myeloma who have previously received at least three lines of treatment. The study is conducted in a real-life setting in Belgium to better understand how teclistamab performs as the next treatment option for these patients. Participants will receive teclistamab as part of their standard clinical care, as this drug is reimbursed for this patient group. Patients will be followed monthly from the start of treatment for the first six months. Afterward, data collection will occur every three months until the study ends, which is up to 24 months or until disease progression, withdrawal, death, or loss to follow-up. During the study, researchers will monitor patients monthly initially and then quarterly, assessing the overall response rate to teclistamab treatment. They will collect data on safety and treatment effectiveness throughout the follow-up period, which lasts up to two years. This approach helps provide a comprehensive view of how patients respond to teclistamab over time.