Dewsbury

Waldenstrf6ms macroglobulinaemia WM is a rare, slow-growing lymphoma that develops due to abnormal growth of white blood cells. This condition mainly affects older adults, with a median age of over 70 years. Current treatments often do not provide lasting responses and can have significant side effects. Researchers are evaluating a chemotherapy-free treatment option combining ibrutinib with rituximab RI to potentially improve treatment outcomes, reduce toxicity, and enhance quality of life compared to the existing chemotherapy regimen. The study compares two treatment groups for adults aged 18 and over with untreated WM. One group receives the experimental chemotherapy-free combination of ibrutinib and rituximab RI, while the control group is treated with the standard chemotherapy regimen of dexamethasone, rituximab, and cyclophosphamide DRC. Treatment cycles last up to six cycles, with response assessments after three cycles and at the end of treatment around 24 weeks. Participants in the RI group may continue with up to five years of ibrutinib alone after randomised treatment. Participants will have regular visits during treatment and then every three months for five years after stopping treatment. Annual follow-up for survival continues until the study ends, which is expected to last over nine years. Researchers will monitor treatment responses, progression-free survival, side effects, overall survival, quality of life using questionnaires, and other outcomes to assess the benefits and risks of the two therapies.

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.