Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)

NCT Number	NCT06409702
Lead Sponsor	The First Affiliated Hospital of Soochow University
Conditions	Newly Diagnosed, High Risk, MRD, Multiple Myeloma
Enrollment	59 participants
Start Date	2024-06-12
Primary Completion	2027-11-30 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-12