Uddevalla

Researchers are investigating whether adding regular radiological scans during follow-up after surgery for high-risk malignant melanoma improves patient survival. This study focuses on patients who have undergone radical surgery for stage IIb-c and III cutaneous malignant melanoma. Since radiological exams can be costly, cause anxiety, and expose patients to radiation, the study aims to determine their value especially given the availability of effective medical treatments for melanoma. Participants are randomly assigned to one of two groups for a 3-year follow-up period. One group receives routine follow-up with regular doctor visits according to national guidelines. The other group receives the same follow-up plus whole body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1000 patients have enrolled. Throughout the study, researchers will monitor overall survival over a 5-year period. Participants will have scheduled assessments including scans and blood tests if assigned to the imaging group. The study also tracks adherence to follow-up visits and any health changes. This approach aims to provide clear evidence on the benefit and impact of imaging during follow-up after melanoma surgery.

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

This research focuses on patients with Relapsed/Refractory Multiple Myeloma (RRMM) who have been treated with the T-cell redirectors teclistamab or talquetamab outside of clinical trials. The study aims to describe the clinical outcomes and safety management of these treatments in a real-world setting, analyzing how patients respond and survive after receiving these therapies. The study does not administer any new interventions but instead collects and analyzes retrospective data from medical records of patients who have received teclistamab or talquetamab. Participants are grouped based on when they received their first dose, covering different time periods up to the end of 2025. This allows the study to assess outcomes for patients treated with these drugs over several years. Throughout the study, researchers will monitor various outcomes, including overall response rates, time to response, duration of response, minimal residual disease status, overall survival, progression-free survival, and time to next treatment. Safety management during treatment is also described. Data will be collected from baseline (day 1) through up to 40 months following treatment initiation, using medical records to understand treatment effects and patient characteristics over time.

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 conducting a multinational, randomized Phase 4 study to evaluate treatments for patients with recurrent non-muscle invasive bladder cancer (NMIBC), specifically those with Ta low-grade tumors. The study aims to determine if a dose-dense chemoablation using Mitomycin C (MMC), followed by adjuvant BCG therapy for non-responders, is more effective for long-term recurrence control than the current standard treatment involving transurethral resection of bladder tumors (TURBT) and adjuvant intravesical therapy. This trial builds on prior research that influenced European treatment guidelines and aims to improve outcomes through a personalized approach based on patient response to chemoablation.

This research aims to understand patient recovery after surgery for benign prostatic hyperplasia (BPH) by studying pain, urinary symptoms, and medication use over three months after different surgical methods. It focuses on three procedures: transurethral resection of the prostate (TUR-P), transurethral vaporization of the prostate (TUV-P), and GreenLight laser enucleation of the prostate (GreenLEP). The study also explores how these outcomes differ among the three surgical techniques and how urinary symptoms change over time using patient-reported data. Patients undergoing one of the three surgeries will complete daily self-assessment forms for three months, reporting pain levels, burning sensations, urine leakage, and presence of blood in urine. They will document their use of pain medications daily. After this period, patients will fill out symptom questionnaires (IPSS) at six months and then annually up to five years. The study includes up to 500 men over 50 years old undergoing surgery at several hospitals in Sweden. Participants will be closely monitored through daily reports during the first three months and longer-term symptom questionnaires to assess changes in urinary tract symptoms. Researchers will analyze pain changes day by day, urinary leakage, medication use, and hematuria duration. The study aims to identify typical recovery patterns and differences among the surgical methods to improve patient care and counseling. Safety and ethical standards will be maintained throughout the study.

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Researchers are conducting a Phase I/IIa multi-center, open-label trial to evaluate the safety and biological effects of ODX (OsteoDex) in adults with relapsed or refractory multiple myeloma. The study aims primarily to assess the safety and tolerability of ODX, while also looking at its preliminary effectiveness based on disease response criteria and effects on specific serum biomarkers. Additionally, the trial explores time to disease progression by monitoring certain protein levels in the blood. Participants will receive up to 7 doses of ODX administered every two weeks, with dosing adjusted across up to three escalating dose levels. Each dose group includes 4 subjects. Treatment continues until unacceptable side effects or disease progression occur. After the last dose, a follow-up visit takes place two weeks later to monitor participants. Throughout the study, researchers will monitor safety by tracking any treatment-related adverse events during the 14-week treatment and follow-up period. Assessments include blood tests for biomarkers, disease response evaluations, and tracking of protein levels related to disease progression. Participants must adhere to scheduled visits and protocol requirements to ensure comprehensive monitoring and data collection during the trial.

Researchers are evaluating treatments for diabetic foot ulcers (DFU) in people with diabetes types 1 or 2, or diabetes due to pancreatitis. The study compares two cleaning agents, Hypochlorous Acid (HClO) and Polyhexamethylene biguanide (PHMB), to see which is more effective in healing DFUs. The main goal is to measure the time it takes for ulcers to fully heal within 24 weeks. Secondary goals include assessing the proportion of ulcers healed within 12 weeks, changes in ulcer size and depth, antibiotic use, quality of life, and cost-effectiveness. The study includes 202 participants who will be randomly assigned to treatment with either HClO or PHMB in a double-blind manner. Cleaning of the ulcers will be done twice a week according to PHMB instructions until the ulcer is completely healed or up to 24 weeks if not healed. Complete healing means the ulcer area is fully covered by intact skin. Additional sub-studies will explore healing patterns, microbiological changes, and quality of life using questionnaires. Participants will be involved in regular wound cleaning sessions twice a week for up to 24 weeks. Researchers will monitor ulcer healing through size and depth measurements and track antibiotic use. Quality of life will be evaluated using the EQ-5D and SF-12 questionnaires. Safety and healing progress will be carefully observed throughout the study period. The total participation time is up to 24 weeks or until complete healing is achieved.