Clinical Trial News

Study on 120 youth with concussions found multimodal physical therapy (PT) safe and effective across early (0-20 days), middle (21-41 days), and late (42+ days) intervention timings, with no significant differences in symptom improvement, PT sessions, or care duration. Early PT initiation may be beneficial, warranting further research.

The VIPER study compares the efficacy of vitrectomy with and without an encircling band for treating pseudophakic retinal detachment (PRD), aiming to determine if adding an encircling band improves outcomes. It also explores if 23/25 G vitrectomy is non-inferior to 20 G vitrectomy. The study involves 14 centers, with experienced surgeons performing the procedures. Primary endpoint is the absence of need for additional retina re-attaching surgery within 26 weeks.

Multiple myeloma, a cancer affecting plasma cells, leads to bone destruction and marrow failure. Incidence is higher in men and those over 65. Advances in therapy, including immune modulators and proteasome inhibitors, have improved survival rates. Lenalidomide, approved for first-line treatment, shows significant efficacy but comes with risks like embryofetal toxicity and hematologic issues.

A study led by Duke Cancer Institute researchers reveals that a tetanus booster significantly improves the effectiveness of a vaccine therapy for glioblastoma, a lethal brain tumor, by enhancing the immune system's response. This innovative approach has shown to dramatically increase patient survival rates, with half of the treated patients living nearly five years or longer.

FDA approved three new drugs for relapsed multiple myeloma: daratumumab, ixazomib, and elotuzumab. Ixazomib, an oral proteasome inhibitor, and elotuzumab, a monoclonal antibody, showed improved progression-free survival in trials. Daratumumab demonstrated single-agent activity, offering new treatment options despite short remission durations.

The Breast Cancer Weight Loss (BWEL) trial investigates the impact of weight loss on reducing cancer recurrence in overweight or obese women with stage II-III breast cancer. This randomized, controlled trial compares a telephone-based weight loss intervention plus health education materials against health education materials alone, aiming for a ≥10% weight loss through increased physical activity and caloric restriction.

Breast cancer mortality in American women is decreasing due to early detection and treatment advances. Palbociclib, combined with letrozole, is FDA-approved for ER+, HER2– metastatic breast cancer, showing improved progression-free survival. Ongoing studies aim to confirm its efficacy and explore its use in other cancers and treatment settings.

FDA announces draft guidance for industry on accelerated approval, detailing requirements for confirmatory trials postapproval to verify drug benefits. It outlines FDA's interpretation of 'underway' and policies for ensuring timely trial completion. Comments on the draft are due by March 10, 2025.

Fulvestrant 500 mg showed improved overall survival (OS) over anastrozole in first-line treatment for ER-positive advanced breast cancer, with a 30% mortality risk reduction. Median OS was 54.1 vs. 48.4 months. Safety profiles were similar, and the OS benefit was consistent across subgroups. The phase III FALCON trial may confirm these findings.

Ropeginterferon alfa-2b, a next-generation mono-pegylated IFN-α-2b, showed promising efficacy and safety in a phase 1/2 study with 51 polycythemia vera patients. Administered every 2 weeks, it achieved a 90% overall response rate without dose-limiting toxicities. The study supports its development in a phase 3 trial.