Isa-VRdlite for of Frail and/or Much Older Patients With High Risk Newly Diagnosed Multiple Myeloma Base on Circulating Plasma Cells

Sponsor
The Affiliated People's Hospital of Ningbo University
Study ID
NCT07732712
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Isatuximab — DRUG
    Newly diagnosed transplant-ineligible multiple myeloma patients (high-risk defined by GA score and circulating plasma cells (CPCs) ≥0.07%) will receive isatuximab plus reduced-intensity VRD (VRDlite) induction therapy, as detailed below: Isatuximab (Isa) 10 mg/kg per administration. Cycle 1: administered on Days 1, 8, 15 and 22. From Cycle 2 onwards: once every two weeks (Days 1 and 15). Dose reduction of isatuximab is prohibited throughout treatment until disease progression, intolerable toxicity, or completion of scheduled therapy. Reduced-intensity VRD (VRDlite) Bortezomib (V): 1.0 mg/m² subcutaneously on Days 1, 8, 15 and 22 of each cycle. Lenalidomide (R): 10 mg orally once daily on Days 1-21 of each cycle; individualized dose reduction shall be performed for patients with renal impairment according to estimated glomerular filtration rate (eGFR).
  • VRD — DRUG
    Newly diagnosed transplant-ineligible multiple myeloma patients (high-risk defined by GA score and circulating plasma cells (CPCs) ≥0.07%) will receive isatuximab plus reduced-intensity VRD (VRDlite) induction therapy, as detailed below: Isatuximab (Isa) 10 mg/kg per administration. Cycle 1: administered on Days 1, 8, 15 and 22. From Cycle 2 onwards: once every two weeks (Days 1 and 15). Dose reduction of isatuximab is prohibited throughout treatment until disease progression, intolerable toxicity, or completion of scheduled therapy. Reduced-intensity VRD (VRDlite) Bortezomib (V): 1.0 mg/m² subcutaneously on Days 1, 8, 15 and 22 of each cycle. Lenalidomide (R): 10 mg orally once daily on Days 1-21 of each cycle; individualized dose reduction shall be performed for patients with renal impairment according to estimated glomerular filtration rate (eGFR).

Study Details

To evaluate the overall response rate, safety, and the 12-cycle clearance rate of circulating plasma cells (CPCs) in patients with newly diagnosed transplant-ineligible multiple myeloma stratified as high-risk based on circulating plasma cell assessment treated with isatuximab combined with reduced-dose VRD regimen

Key Dates

First listed
Jul 29, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Isa-VRdlite for high risk fail MM patinets base on CPSc
    Isa-VRdlite for high risk fail MM patinets base on CPSc

Primary Outcome Measure

Overall response rate [ Time Frame: 12months ]

Central Contacts

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