NCT06963866Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 9 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Xuzhou Medical University
- Diseases
- Multiple myeloma
- NCT number
- NCT06963866
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 May 2025 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
Other
- Pregnant or lactating women, or women planning to become pregnant within the next six months;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital oh Xuzhou Medical University Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.