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RECRUITING
NCT06409702
PHASE4

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

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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)

Official title: A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2024-06-12

Completion Date

2027-12-31

Last Updated

2025-06-12

Healthy Volunteers

No

Interventions

DRUG

Carfilzomib

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

DRUG

Daratumumab

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

DRUG

Lenalidomide

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

DRUG

Dexamethasone

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

DRUG

VRD for first-cycle induction therapy

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)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China