Effective Quadruplet Utilization After Treatment Evaluation EQUATE A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

What this Trial Is About

Researchers are evaluating treatments for adults with newly diagnosed multiple myeloma, a type of plasma cell cancer. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination without bortezomib. The study aims to find out if adding bortezomib improves overall and progression-free survival, response rates, and patient quality of life while monitoring side effects and disease markers like minimal residual disease MRD. All participants first receive a standard induction therapy with daratumumab, lenalidomide, and dexamethasone over about 9 cycles of 28 days each. After this, patients are randomly assigned to one of two consolidation and maintenance treatments one group receives bortezomib along with the other drugs for consolidation followed by maintenance with daratumumab and lenalidomide the other group receives consolidation and maintenance without bortezomib. Treatments are given by subcutaneous injection or orally at specified days and cycles. Patients are followed long-term for up to 15 years after study entry. During the trial, patients undergo regular assessments including blood and urine tests, bone marrow biopsies, and imaging scans like PETCT to measure disease status and treatment response. Patient-reported outcomes on symptoms like neuropathy and quality of life are also collected. Safety is closely monitored through adverse event reports. Follow-up visits occur every 3 months initially, then less frequently over time to track survival and health outcomes.

Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial