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

ConditionsMultiple MyelomaNewly Diagnosed
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CAR-T

    Biological/Vaccine

    The T cells are genetically modified to expressa chimeric antigen receptor targeting BCMA andare infused after induction therapy at a target dose of ≥2.0×10\^6 cells/kg

  • ASCT

    Biological/Vaccine

    Patients in this arm will receive autologous hematopoietic stem cell transplantation (ASCT).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ASCTActive comparator 1 intervention
Group B: CAR-TExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 36 months after CAR-T infusion
2

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.

Time frame
Up to 36 months after CAR-T infusion]

Secondary outcomes

1

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the proportion of patients achieving a response of partial response (PR) or better, including PR, very good partial response (VGPR), complete response (CR), and stringent complete response (sCR), according to the International Myeloma Working Group (IMWG) criteria. The assessment will be based on laboratory parameters, imaging, and bone marrow evaluation, as applicable.

Time frame
Up to 36 months after CAR-T infusion
2

MRD

The proportion and immunophenotype of plasma cells in bone marrow were analyzed using flow cytometry, with a sensitivity of 10\^-5.

Time frame
Up to 36 months after CAR-T infusion
3

Adverse Events (AE)

Focus on adverse events related to ASCT and CAR-T, including CRS, ICANS, coagulation disorders, infections, and other complications.

Time frame
Up to 36 months after CAR-T infusion

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: