NCT06963866

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
25mo left

Started May 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
May 2025Apr 2028

First Submitted

Initial submission to the registry

April 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

May 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

April 30, 2025

Last Update Submit

April 30, 2025

Conditions

Multiple Myeloma, Newly Diagnosed

Keywords

Multiple MyelomaEligible for ASCTASCTCAR-T

Outcome Measures

Primary Outcomes (2)

  • Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) is defined as the time from the date of CAR-T cell infusion to the date of disease progression or death from any cause, whichever occurs first. Disease progression will be determined based on the International Myeloma Working Group (IMWG) criteria. Patients who have not progressed or died will be censored at the date of last follow-up.

    Up to 36 months after CAR-T infusion

  • Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the date of CAR-T cell infusion to death from any cause. Patients who are alive at the time of analysis will be censored at their last known date of follow-up.

    Up to 36 months after CAR-T infusion

Secondary Outcomes (3)

  • Objective Response Rate (ORR)

    Up to 36 months after CAR-T infusion

  • MRD

    Up to 36 months after CAR-T infusion

  • Adverse Events (AE)

    Up to 36 months after CAR-T infusion

Study Arms (2)

ASCT + CAR-T

EXPERIMENTAL

ASCT followed by BCMA CAR-T

Biological: autologous stem cell transplantationBiological: CAR-T

ASCT alone

ACTIVE COMPARATOR

ASCT alone, without CAR-T infusion

Biological: autologous stem cell transplantation

Interventions

autologous stem cell transplantationBIOLOGICAL

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

ASCT + CAR-TASCT alone
CAR-TBIOLOGICAL

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.

ASCT + CAR-T

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital oh Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Kailin Xu

    The Affiliated Hospital oh Xuzhou Medical University

    STUDY CHAIR

Central Study Contacts

Kailin Xu

CONTACT

15162166166lihmd@163.com

Kailin Xu

CONTACT

+8615162166166lihmd@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Hematologist of The Affiliated Hospital of Xuzhou Medical University

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 9, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

May 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)