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NCT07732712Not yet recruitingPhase 2/3

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

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
15 (estimated)
First submitted
16 Jul 2026
Start date
1 Jan 2027
Primary completion date
31 Dec 2028
Lead sponsor
The Affiliated People's Hospital of Ningbo University
NCT number
NCT07732712

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 15
  • From 1 Jan 2027 to the primary completion date, 31 Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.