Dewsbury

Waldenstrf6m's macroglobulinaemia (WM) is a rare, slow-growing lymphoma where abnormal white blood cells develop, mostly affecting older adults with a median age over 70. Current treatments often lead to incomplete responses and disease recurrence, so this study seeks better first-line therapies to improve outcomes and quality of life. The RAINBOW trial is a combined phase 2 and 3 study comparing a chemotherapy-free regimen to standard chemotherapy in patients newly diagnosed with WM. The study compares two treatment plans: one group receives rituximab and ibrutinib (RI) without chemotherapy, while the other group receives the standard combination of dexamethasone, rituximab, and cyclophosphamide (DRC). Eligible adults with untreated WM will be randomly assigned to either group and receive up to 6 treatment cycles. Those on the RI arm may continue ibrutinib alone for up to 5 years after initial therapy. Treatment response is assessed after 3 cycles and at 24 weeks. Participants will be closely monitored throughout treatment and then every 3 months for 5 years after stopping therapy. Annual follow-up for survival continues until the trial ends, which is expected to last about 9 and a half years. Researchers measure treatment effectiveness by overall response rates at 24 weeks and progression-free survival up to 2 years after the last patient is randomized, with ongoing safety and quality of life assessments.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant (ASCT). This phase III, open-label, randomized, controlled study aims to evaluate whether adding a proteasome inhibitor to the salvage ASCT conditioning improves the depth of response, and to assess the impact of consolidation and maintenance treatments on the durability of response. The study also looks at overall survival, progression time, quality of life, and treatment safety among participants with measurable disease and good performance status. All participants first receive re-induction therapy consisting of 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone (ITD) over 28-day cycles to achieve maximum disease control. Those who reach stable disease or better are randomized to receive either conventional ASCT using melphalan or augmented ASCT combining melphalan with ixazomib. Following this, participants who maintain minimal response or better undergo a second randomization to either receive consolidation therapy with 2 cycles of ITD followed by ixazomib maintenance until disease progression, or no further treatment. During the study, participants will undergo regular assessments including blood tests, disease response evaluations, and monitoring for adverse effects. The primary outcomes measured are overall response rate 100 days after ASCT and progression-free survival up to 10 years. Secondary evaluations include overall survival, time to disease progression, minimal residual disease status at various stages, engraftment kinetics, and quality of life. Follow-up continues with clinic visits every three months until disease progression is observed, enabling long-term monitoring of treatment effects and safety.