Tests CAR-T cell therapy after stem cell transplant in newly diagnosed myeloma
Compares stem cell transplant followed by CAR-T therapy with transplant alone in adults.
Plain-language title generated from the registry record
Registry title: Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT
Key facts
- Where
- Xuzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06963866, who can take part
Where in China
- The Affiliated Hospital oh Xuzhou Medical UniversityXuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuzhou Medical University
- Trial code
- NCT06963866
- Record updated
- 9 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age between 18 and 70 years (inclusive); Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN); Karnofsky Performance Status (KPS) score > 50%; Eligible for ASCT.
Exclusion: History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2); Significant dysfunction of vital organs including the heart, lungs, or brain; Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study; Transduction efficiency of targeted lymphocytes <10%, or expansion fold <5× under CD3/CD28 co-stimulation, as determined by feasibility screening; Pregnant or lactating women, or women planning to become pregnant within the next six months.