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

NCT07732712 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-MM-1
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Overall response rate

  defined as the proportion of patients achieving stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] or partial response \[PR\]

  12months

• 12-cycle clearance rate of circulating plasma cells (CPCs).

  12-cycle clearance rate of circulating plasma cells (CPCs).

  12months

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Isatuximab; Drug: VRD

Interventions

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): 1.3 mg/m², subcutaneous injection, Days 1, 8, 15, 22 per cycle. This administration route reduces the incidence of peripheral neuropathy. Lenalidomide (R): 15 mg once daily orally, Days 1-21 per cycle. Dose should be further individualized and reduced for patients with renal insufficiency according to eGFR Dexamethasone (D): 20 mg once daily, orally or intravenously

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

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): 1.3 mg/m², subcutaneous injection, Days 1, 8, 15, 22 per cycle. This administration route reduces the incidence of peripheral neuropathy. Lenalidomide (R): 15 mg once daily orally, Days 1-21 per cycle. Dose should be further individualized and reduced for patients with renal insufficiency according to eGFR

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated People's Hospital of Ningbo University: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Yuxiao Wang

CONTACT

+8613486889847; 799161574@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share