Multiple myeloma
Conditions
Interventions
Intervention group:autologous hematopoietic stem cell transplantation combined with CAR-T cell therapy
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Meets the International Myeloma Working Group (IMWG) diagnostic criteria for multiple myeloma (MM). - Relapsed/refractory multiple myeloma (RRMM) is defined as: Disease relapse or progression after at least 2 lines of treatment (including proteasome inhibitors and immunomodulatory drugs). Resistant to the most recent treatment regimen (refractory). Patients classified as high-risk or ultra-high-risk according to R2-ISS or MPSS. 2. Age and Performance Status - Age 18-75 years. - Eastern Cooperative Oncology Group (ECOG) performance status = 50%. - Lung function: pulmonary function tests (PFT) showing FEV1 and DLCO >= 50% of predicted values. - Liver function: total serum bilirubin = 30 mL/min (excluding myeloma-related renal impairment). 4. Hematopoietic Function - Adequate bone marrow hematopoiesis, absolute neutrophil count (ANC) >= 1.0×10?/L, platelet count >= 50×10?/L. - Suitable for autologous hematopoietic stem cell collection (CD34 cells >= 2×106/kg). 5. Treatment History - Patient has not previously received CAR-T cell therapy. - Patient has not previously undergone allogeneic hematopoietic stem cell transplantation. 6. Informed Consent - Patient has signed the informed consent form, voluntarily participating in the study and accepting treatment.
Exclusion criteria
Exclusion criteria: 1. Disease-related - Concomitant other malignant tumors (excluding non-melanoma skin cancer or carcinoma in situ). - Presence of central nervous system involvement (such as plasmacytoma or meningeal lesions). 2. Infection and immune status - Active infections (such as HIV, HBV, HCV, tuberculosis, etc.) that are uncontrolled. - Severe immunodeficiency or requiring long-term immunosuppressive therapy. 3. Organ dysfunction - Severe heart failure (e.g., NYHA class III or IV). - Severe liver or kidney dysfunction (e.g., cirrhosis, renal failure). - Presence of uncontrolled pulmonary disease (e.g., interstitial lung disease, severe chronic obstructive pulmonary disease). 4. Treatment-related - Previous CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation. - Chemotherapy, radiotherapy, or other anti-tumor treatments within 4 weeks before enrollment. - Contraindications to drugs related to CAR-T cell therapy (e.g., fludarabine, cyclophosphamide). 5. Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life; | — |
Countries
China
Contacts
Public ContactSongfu Jiang
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed