Clinical trial · Interventional

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

NCT07070934CI-TRIAL-00092300ASCTvsCAR-Tnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92
Newly Diagnosed	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
ASCT	Biological	—	UNRESOLVED
CAR-T	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
ASCT
description
ASCT alone
interventionNames
1. Biological: ASCT
type
EXPERIMENTAL
label
CAR-T
description
CAR-T alone
interventionNames
1. Biological: CAR-T

Primary outcomes (2)

measure
Progression-Free Survival (PFS)
timeFrame
Up to 36 months after CAR-T infusion
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age between 18 and 70 years (inclusive);
2. Estimated life expectancy of more than 12 weeks;
3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;
4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);
5. Karnofsky Performance Status (KPS) score \> 50%.
6. Eligible for ASCT.

Exclusion Criteria:

1. Pregnant or lactating women, or women planning to become pregnant within the next six months;
2. Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);
4. Significant dysfunction of vital organs including the heart, lungs, or brain;
5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

References

Publications (0)

Data not yet available

No reference posted for this study.