Not Yet RecruitingPhase 2

CAR-T vs. Auto-SCT: Which Works Better for New Myeloma Patients?

60 participantsStarted 2025-07-15

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Pregnant or lactating women, or women planning to become pregnant within the next six months;
✕. Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
✕. 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

What they're measuring

Progression-Free Survival (PFS)

Timeframe: Up to 36 months after CAR-T infusion

Overall Survival (OS)

Timeframe: Up to 36 months after CAR-T infusion]

Trial details

NCT IDNCT07070934

SponsorXuzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

Contact for this trial

Kailin Xu

+8615162166166 lihmd@163.com

View on ClinicalTrials.gov More Multiple Myeloma trials