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To investigate the effectiveness and safety of up-front consolidation with BCMA-targeted CAR T-cell for newly diagnosed multiple myeloma

To investigate the effectiveness and safety of up-front consolidation with BCMA-targeted CAR T-cell for newly diagnosed multiple myeloma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046374
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-05-15
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma

Interventions

CAR T cell first-line consolidation group:CAR T-cell

Sponsors

The Affiliated Hospital of Jiangsu University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed multiple myeloma patients; 2. Aged more than 18 years and less than 70 years; 3. Suitable for transplantation or uncomfortable transplantation; 4. Estimated survival time> 12 weeks; 5. The ECOG PS score is less than 2 points; 6. The patient has no serious liver, cardiovascular and cerebrovascular diseases; 7. The patient has no infectious diseases such as HIV, active tuberculosis, and syphilis; 8. The patient does not have other malignant tumors at the same time; 9. If the patient has renal insufficiency, GFR>30mL/min is required; 10. Able to understand and voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breastfeeding, or women who have a pregnancy plan within six months; 2. The feasibility assessment and screening prove that the transfection of targeted lymphocytes is <10% or the expansion is insufficient under CD3/CD28 co-stimulation (< 5 times); 3. Abnormal vital signs, and those who cannot cooperate with the examination; 4. People with mental or mental illnesses who cannot cooperate with treatment and efficacy evaluation; 5. Subjects requiring anti-infection treatment for systemic infections or severe local infections; 6. Subjects with severe autoimmune diseases; 7. The doctor believes that there are other reasons that cannot be included in the treatment.

Design outcomes

Primary

MeasureTime frame
saftey;effectiveness;

Secondary

MeasureTime frame
Progression-free survival;MRD;Time to relapse;

Countries

China

Contacts

Public ContactFei Xiaoming

Department of Hematology, Affiliated Hospital of Jiangsu University

feixiaomingujs@aliyun.com+86 511 85026722

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026