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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06409702
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carfilzomib — DRUG
    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
  • Daratumumab — DRUG
    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
  • Lenalidomide — DRUG
    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
  • Dexamethasone — DRUG
    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
  • VRD for first-cycle induction therapy — DRUG
    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。

Study Details

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)

Key Dates

Start date
Jun 12, 2024
Status verified
Jun 2025
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DKRd
    All patients will be treated with VRD induction for first-cycle,and then DKRD induction and consolidation therapy for following 5\~7 cycles, then maintenance therapy.

Primary Outcome Measure

MRD negative rate [ Time Frame: Completion of consolidation therapy ]

Central Contacts

Related Studies