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Not yet recruiting NCT07732712

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

Phase II / Phase III Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isatuximab, VRD.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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 toxic
  • 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 toxic

Primary outcome measures

  • Overall response rate [Time frame: 12months]
  • 12-cycle clearance rate of circulating plasma cells (CPCs). [Time frame: 12months]

Eligibility criteria

Inclusion criteria

  • Aged ≥ 18 years with newly diagnosed symptomatic multiple myeloma who have not received any prior anti-myeloma therapy.
  • Confirmed positive circulating abnormal plasma cells (CPCs) in peripheral blood via flow cytometry (CPCs ≥ 0.07%).
  • Deemed ineligible for autologous hematopoietic stem cell transplantation due to advanced age, poor physical performance, or underlying comorbidities precluding transplant tolerance.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
  • Estimated life expectancy of at least 6 months.
  • Adequate baseline function of major vital organs to tolerate treatment; no absolute contraindications on complete blood count, liver and renal function, cardiac enzymes or coagulation profile.
  • Voluntarily participate in this study, provide written informed consent, and be available for regular follow-up visits.

Exclusion criteria

  • Diagnosis of primary plasma cell leukemia, solitary plasmacytoma, smoldering multiple myeloma or secondary multiple myeloma.
  • Prior exposure to any anti-myeloma agents, radiotherapy, or stem cell transplantation.
  • Concurrent other malignant tumors (except for in situ carcinoma cured for more than 5 years).
  • Severe active infection, active autoimmune disease, or severe cardiovascular and cerebrovascular diseases (NYHA class III-IV heart failure, recent myocardial infarction or cerebral infarction).
  • Known hypersensitivity to isatuximab, bortezomib, lenalidomide, dexamethasone, or any excipients of the study drugs.
  • Pregnant or breastfeeding females.
  • Unwilling or unable to complete follow-up, or patients with incomplete clinical data.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07732712 · 2026-MM-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗