A Phase 3 Study Comparing Daratumumab, VELCADE (borte-zomib), Lenalidomide, and Dexamethasone (D-VRD) vs VELCADE, Lenalidomide, and Dexamethasone (VRD) in Sub-jects with Previously Untreated Multiple Myeloma who are Eligi-ble for High-dose Therapy
Laufend - Rekrutierung – laufend · 2019 bis 2029
This is a randomized, open-label, multicenter study evalu-ating subjects with newly diagnosed multiple myeloma who are deemed eligible for high-dose therapy. Approximately 690 subjects will be stratified by International Staging Sys-tem (ISS) Stage I, II, or III disease (β-2 microglobulin and albumin) and cytogenetics (standard risk or high risk as defined by presence of del17p, t[4;14] or t[14;16]), and then randomized in a 1:1 ratio. In Arm A, subjects will receive VRd for induction and consolidation, followed by lenalido-mide (R) maintenance until disease progression. Subjects in Arm B will receive D-VRd for induction and consolidation followed by daratumumab and lenalidomide maintenance until disease progression. MRD-negative subjects in Arm B will stop therapy with daratumumab after sustained MRD negativity (at or below the threshold of 10-5) for 12 months and a minimum of 24 months of maintenance therapy. These subjects will continue lenalidomide maintenance therapy until disease progression. After stopping daratu-mumab therapy, subjects with sustained MRD negativity should restart therapy with daratumumab if there is a recur-rence of MRD at 10-4 or higher or a confirmed loss of CR without disease progression, as evidenced by reappear-ance of serum or urine monoclonal protein (M-protein) or increase to ≥5% plasma cells in bone marrow After reinitiat-ing daratumumab, the subject will continue daratumumab and lenalidomide therapy until disease progression.