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

NCT07732712 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-07-29

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Isatuximab

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).

DRUG

VRD

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).

Sponsors & Collaborators

  • The Affiliated People's Hospital of Ningbo University

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-08-01
Completion
2028-12-01

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Entities

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 NCT07732712 on ClinicalTrials.gov