Almere

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in adults with newly diagnosed multiple myeloma. This phase 3 study aims to determine which maintenance treatment better supports patients following their initial transplant and induction therapies. Participants must have responded to prior treatments and undergone ASCT within specified time frames. Participants will receive either iberdomide or lenalidomide at specified doses on scheduled days as maintenance therapy after their ASCT. The study is randomized, multi-center, and open-label, meaning both participants and researchers know which treatment is given. The treatments will be administered following a standard induction therapy including proteasome inhibitors, immunomodulatory drugs, and possibly monoclonal antibodies, with or without consolidation after transplant. Throughout the study, participants will be monitored for progression-free survival for up to 6 years to assess how well the maintenance therapies prevent disease progression. Researchers will also evaluate safety and treatment response according to established myeloma criteria. Regular assessments will include clinical evaluations and monitoring for any signs of disease relapse or adverse effects over the long term.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

Researchers are evaluating how well sonrotoclax combined with obinutuzumab or rituximab compares to venetoclax plus rituximab in treating adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 3, open-label study will also assess the safety of these treatment combinations. The study is sponsored by BeOne Medicines, previously known as BeiGene, and involves multiple centers. Participants will receive one of the following treatments: sonrotoclax taken orally with intravenous obinutuzumab, sonrotoclax taken orally with intravenous rituximab, or venetoclax taken orally with intravenous rituximab. The treatments are given according to the study protocol, and participants are randomly assigned to one of these groups. The study monitors how these combinations work over time. During the study, participants will be regularly assessed through evaluations such as imaging, laboratory tests, and physical exams to monitor disease progression and treatment effects. Researchers will measure progression-free survival, which is how long participants live without disease worsening, with follow-up lasting up to about 51 months. Safety is also closely monitored to understand any side effects. The total duration of participation depends on the individual treatment and follow-up schedules.

Researchers are investigating how exercise affects patients with metastatic colorectal cancer receiving chemotherapy. The study explores whether exercise can prevent chemotherapy dose changes caused by treatment side effects, improve immune function, and ultimately enhance progression-free survival. The trial also seeks to determine the best type and dose of exercise to recommend, as current evidence on optimal exercise prescription is limited. Using a Bayesian adaptive design allows for more efficient evaluation by potentially dropping less effective exercise programs early. Participants will be randomly assigned to one of three groups: resistance exercise, aerobic interval exercise, or usual care without a specific exercise program. The exercise interventions involve continuous aerobic and resistance exercises or continuous aerobic and aerobic interval exercises. These programs aim to reduce chemotherapy toxicity and improve psychological and physical strength. The study uses a multi-arm multi-stage design with interim analyses to select the most beneficial exercise prescription while minimizing patient exposure to less effective treatments. Throughout the study, participants will be monitored for chemotherapy dose modifications and progression-free survival for up to two years. Assessments include tracking chemotherapy dose adjustments during treatment cycles, immune function by evaluating natural killer cells, and quality of life measures. Researchers will also observe treatment-related toxicities and hospitalizations. The trial aims to provide evidence on how exercise can support chemotherapy effectiveness and improve outcomes in metastatic colorectal cancer patients.

Researchers are evaluating the safety and effectiveness of a medicine called NNC0487-0111 for adults with excess body weight, specifically targeting obesity. This Phase 3 clinical study aims to see if this treatment helps people maintain their weight loss compared to a placebo, which contains no active medicine. Participants are randomly assigned to either the treatment or placebo group to fairly compare results. The study involves two groups receiving weekly injections under the skin: one group gets NNC0487-0111, and the other receives a placebo designed to look the same. The treatment is given once a week, and participants reach a target dose during an initial run-in period before the main study phase begins. During the study, researchers track changes in body weight from week 40 to week 92 to assess how well the treatment works. Participants' safety and health are monitored throughout the study, including various medical assessments. The total participation time covers these weeks and includes ongoing observation to understand the treatment's effects over time.

Researchers are evaluating how the body absorbs essential amino acids from two different protein sources: full fat yogurt (fermented) and generic full fat pasteurized milk (non-fermented). The study aims to compare the early bioavailability of amino acids in healthy adults aged 18 to 40 years. This randomized controlled clinical trial focuses on understanding the amino acid levels in blood after consuming these products. Participants will visit the study site twice while fasting. Each visit involves consuming one serving of either the yogurt or milk product in a random order within about 10 minutes. Blood samples will be collected at baseline and at 14 time points after product intake to measure amino acid levels. After the final visit, participants will receive a follow-up call 7 days later to check on their status. During the study, participants will undergo multiple blood draws to assess the amino acid response over 2 hours after eating. Researchers will monitor essential amino acid levels in the blood to determine differences between the two products. The total study participation includes two visits with blood sampling and a follow-up call approximately one week later to ensure safety and gather additional information.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Chronic fatigue is a common and complex symptom affecting about 30% of people in the Netherlands for more than six months. This study evaluates how often diagnostic tests during fatigue consultations at an internal medicine outpatient clinic lead to a somatic diagnosis. It also explores the experiences of patients who do not receive a diagnosis after such consultations. The study uses both a retrospective quantitative analysis and a prospective qualitative interview approach to better understand this condition and improve patient care. The study includes two parts: first, a retrospective review of medical records from the clinic to see how blood work, electrocardiograms (ECG), and chest X-rays contribute to diagnosing fatigue. Second, qualitative interviews based on Grounded Theory will be conducted with patients who left the consultation without a somatic diagnosis. These interviews will explore patient experiences at 1-2 months, 6 months, and one year after their consultation. Participants are adults referred for unexplained fatigue to the internal medicine outpatient clinic. Researchers will collect diagnostic results and patient insights through interviews. The study aims to improve understanding of diagnostic outcomes and patient experiences with chronic fatigue, potentially enhancing clinical care. Outcome measures include blood work, ECG, chest X-ray results determined retrospectively after two weeks, and patient interview data collected over one year.