NCT07070934Not yet recruitingPhase 2
CAR-T vs. Auto-SCT: Which Works Better for New Myeloma Patients?
A Multicenter, Open-label, Randomized Controlled Trial Comparing Anti-BCMA CAR-T Cell Therapy Versus Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 17 Jul 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 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
- 8 Jul 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 15 Jul 2026
- Lead sponsor
- Xuzhou Medical University
- Diseases
- Multiple myeloma
- NCT number
- NCT07070934
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 15 Jul 2025 to the primary completion date, 15 Jul 2026
- No sites listed in no 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
This page is information, not medical advice. Discuss any trial with your doctor.