Grantham

Researchers are collecting real-world data on patients undergoing rotator cuff repair using the REGENETEN Bioinductive Implant System. This prospective, single-arm, multicenter registry involves up to 50 centers across the United Kingdom, Europe, and Australia, aiming to enroll up to 400 patients. The study focuses on evaluating clinical and health economic outcomes after surgery for rotator cuff injuries. Participants receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant, a device designed to manage and protect tendon injuries without substantial tendon tissue loss. Patients are treated according to standard medical care, and the study gathers data on their recovery and outcomes over time. Participants will be monitored up to two years after surgery with regular assessments including quality of life, arm and shoulder function, pain levels, and shoulder-specific scores at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Additional data on retear rates, postoperative recovery, sling use, mobilization time, and return to work are also collected. The study provides long-term insight into patient progress following the use of the implant.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.