Phase 3 Trial Comparing Four-Drug and Three-Drug Combination Therapies for Adults with Newly Diagnosed Multiple Myeloma Not Intended for Early Transplant

What this Trial Is About

Researchers are evaluating a combination therapy approach for adults with newly diagnosed multiple myeloma who are not intended for early autologous transplantation. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination of daratumumab, lenalidomide, and dexamethasone. The study aims to determine whether adding bortezomib improves overall survival and progression-free survival, examining minimal residual disease status and patient-reported outcomes related to neuropathy and quality of life. All participants first receive standard induction therapy with daratumumab administered subcutaneously on scheduled days, oral lenalidomide daily for 21 days per cycle, and oral dexamethasone on specific days, repeated every 28 days for 9 cycles. After induction, patients are randomized to either receive consolidation with bortezomib plus daratumumab, lenalidomide, and dexamethasone followed by maintenance with daratumumab and lenalidomide, or consolidation with daratumumab, lenalidomide, and dexamethasone followed by the same maintenance regimen. Consolidation cycles repeat every 28 days for 9 cycles, and maintenance cycles repeat every 28 days until disease progression or unacceptable toxicity. Participants undergo regular monitoring including imaging with PETCT scans, bone marrow biopsies for minimal residual disease assessment, and laboratory tests throughout induction, consolidation, and maintenance phases. Patient-reported outcomes on neuropathy and quality of life are collected, alongside safety monitoring for adverse events. After completing study treatment, participants are followed every 3 months for up to 2 years, then every 6 months up to 5 years, and annually up to 15 years to evaluate long-term outcomes and survival.

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