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Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT

NCT06963866 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-09

No results posted yet for this study

Summary

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

  • Multiple Myeloma, Newly Diagnosed

Interventions

BIOLOGICAL

autologous stem cell transplantation

Patients in this arm will receive autologous hematopoietic stem cell transplantation (ASCT). Prior to ASCT, the patients underwent 3-4 cycles of induction chemotherapy.

BIOLOGICAL

CAR-T

The T cells are genetically modified to express a chimeric antigen receptor targeting BCMA and are infused 3 days after ASCT at a target dose of ≥2.0×10\^6 cells/kg.

Sponsors & Collaborators

  • Xuzhou Medical University

    lead OTHER

Principal Investigators

  • Kailin Xu · The Affiliated Hospital oh Xuzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06963866 on ClinicalTrials.gov