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

NCT06409702 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-06-12

No results posted yet for this study

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)

Conditions

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。

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2027-11-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06409702 on ClinicalTrials.gov