Clinical trial · Interventional
BCMA CAR-T Versus ASCT in Transplant-eligible Patients With Multiple Myeloma
A Prospective, Non-inferiority Study Comparing VRD±D Followed by BCMA CAR-T Cell Therapy Versus VRD±D Followed by Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly-diagnosed Multiple Myeloma
NCT06793449CI-TRIAL-00093017CAREMM-006recruitingPhase 2ClinicalTrials.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)
This is a prospective, non-inferiority study comparing VRD±D followed by BCMA CAR-T cell therapy versus VRD±D followed by autologous hematopoietic stem cell transplantation in the treatment of newly diagnosed multiple myeloma patients.
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 |
|---|---|---|---|
| anti-BCMA CAR-T | Biological | — | UNRESOLVED |
| ASCT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ASCT
- description
- Patients will receive 3-4 cycles induction treatment, and high-dose melphalan conditioning, followed by autologous transplantation.Three months post-transplant, patients will undergo 2-3 cycles of consolidation therapy, followed by maintenance therapy for ≥2 years or until disease progression, death, intolerance, withdrawal for other reasons, or the study's termination/completion.
- interventionNames
- Biological: ASCT
- type
- EXPERIMENTAL
- label
- BCMA CAR-T
- description
- Patients will receives 3-4 cycles of induction therapy, 2-3 cycles of consolidation treatment, followed by Fc-based conditioning and CAR-T cell infusion. One month after CAR-T cell therapy, patients will begin maintenance therapy for ≥2 years or until disease progression, death, intolerance, withdrawal for other reasons, or the study's termination/completion.
- interventionNames
- Biological: anti-BCMA CAR-T
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be informed and voluntarily sign the Informed Consent Form (ICF). 2. Age between 18 and 70 years (inclusive). 3. Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (\>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L. 4. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry. 5. Assessed by the investigator as transplant-eligible. Exclusion Criteria: 1. Primary plasma cell leukemia. 2. Concurrent amyloidosis. 3. Involvement of the central nervous system (CNS). 4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.