Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
The First Affiliated Hospital of Soochow University
59 participants
Jun 12, 2024
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
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Interventions
Induction: ASCT：20mg/56mg/m2 ,D1,8,15，C2-4; non ASCT: 20mg/36mg/m2 ,D1,8,15，C2-4; Consolidation: ASCT: 56mg/m2 ,D1,8,15，C5-6; non ASCT: 36mg/m2 ,D1,8,15，C5-8; Maintenance: ASCT: 70mg/m2 ，D1，15; non-ASCT：56mg/m2 ，D1，15 After consolidation therapy, if MRD negativity is sustained for more than 1 year, carfilzomib will be discontinued
28d/Cycle Induction: 16mg/kg, D1,8,15,22，C 2-3，16mg/kg, D1,15, C4; Consolidation: ASCT: 16mg/kg/d, D1,15,C5-6; non ASCT: 16mg/kg/d, D1,15,C5-8; Maintenance: 16mg/kg, D1,monthly After consolidation therapy, if MRD negativity is sustained for more than 1 year, daratumumab will be discontinued
28d/Cycle Induction: 25mg qd d1-21 C2-C4; Consolidation: ASCT: 10mg d1-21，C5-6; non ASCT: 25 mg d1-21，C5-8; Maintenance: 10mgqd D1-21 After consolidation therapy, if MRD negativity is sustained for more than 1 year, lenalidomide monotherapy will be maintained until disease progression
28d/Cycle Induction: ASCT：40mg qd, po/iv，D1,8,15,22，C2-4; non ASCT:20mg qd, po/iv，D1,8,15,22，C2-4; Consolidation: ASCT: 40mg qd, po/iv，D1,8,15,22，C5-6; non ASCT:20mg qd, po/iv，D1,8,15,22，C5-8
Induction: C1, 28d/cycle Bortezomib(V）:1.3 mg/m2，H，d1、4、8、11； Lenalidomide(R)：25mg，po. qd d1-14; Dexamethasone(D)：20 mg，po/iv，D1，2, 4，5, 8，9, 11,12。
Locations(1)
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NCT06409702