Clinical trial · Interventional
Isa-VRdlite for of Frail and/or Much Older Patients With High Risk Newly Diagnosed Multiple Myeloma Base on Circulating Plasma Cells
NCT07732712CI-TRIAL-00119817not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isatuximab | Drug | Isatuximab | ALIAS |
| VRD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Isa-VRdlite for high risk fail MM patinets base on CPSc
- description
- Isa-VRdlite for high risk fail MM patinets base on CPSc
- interventionNames
- Drug: Isatuximab
- Drug: VRD
Primary outcomes (2)
- measure
- Overall response rate
- timeFrame
- 12months
- description
- defined as the proportion of patients achieving stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] or partial response \[PR\]
- measure
- 12-cycle clearance rate of circulating plasma cells (CPCs).
- timeFrame
- 12months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.