Clinical trial · Interventional
Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT
A Multicenter, Open-Label, Randomized, Controlled Study of Autologous Stem Cell Transplantation Followed by Anti-BCMA CAR-T Therapy Versus ASCT Alone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma
NCT06963866CI-TRIAL-00089467ASCTvsCAR-Tnot yet recruitingPhase 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 study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone 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, Newly Diagnosed | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous stem cell transplantation | Biological | — | UNRESOLVED |
| CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ASCT + CAR-T
- description
- ASCT followed by BCMA CAR-T
- interventionNames
- Biological: autologous stem cell transplantation
- Biological: CAR-T
- type
- ACTIVE_COMPARATOR
- label
- ASCT alone
- description
- ASCT alone, without CAR-T infusion
- interventionNames
- Biological: autologous stem cell transplantation
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Up to 36 months after CAR-T infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 70 years (inclusive); 2. Estimated life expectancy of more than 12 weeks; 3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies; 4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN); 5. Karnofsky Performance Status (KPS) score \> 50%. 6. Eligible for ASCT. Exclusion Criteria: 1. Pregnant or lactating women, or women planning to become pregnant within the next six months; 2. Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening; 3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2); 4. Significant dysfunction of vital organs including the heart, lungs, or brain; 5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.