Multiple Myeloma
Conditions
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
Interventions
DRUGVRD
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).
DRUGIsatuximab
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
The Affiliated People's Hospital of Ningbo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 12months | defined as the proportion of patients achieving stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] or partial response \[PR\] |
| 12-cycle clearance rate of circulating plasma cells (CPCs). | 12months | 12-cycle clearance rate of circulating plasma cells (CPCs). |
Contacts
CONTACTYuxiao Wang
Outcome results
None listed