Relapsed or refractory multiple myeloma
Conditions
Interventions
ASCT followed by BCMA CAR-T group:None
Sponsors
Shanxi Bethune Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years with relapsed/refractory multiple myeloma (MM) (meeting the IMWG diagnostic criteria); 2.Have received at least one prior line of systemic therapy; 3.ECOG performance status of 0 to 2; 4.Meet the conditions for receiving autologous hematopoietic stem cell transplantation and BCMA CAR-T cell therapy, with major organ functions generally normal and able to tolerate the related treatment; 5.Patients must be able to understand the potential changes and corresponding management during the treatment and follow-up period, and have good compliance with the treatment plan and follow-up schedule; 6.Participate voluntarily in this study and sign a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Severe dysfunction of vital organs such as the heart, lungs, and liver (e.g., cardiac ejection fraction below 50%, carbon monoxide diffusion capacity below 50% of the predicted value due to chronic respiratory disease, serum; 2.Toxicity from prior chemotherapy in relapsed MM patients has not recovered to baseline levels (= Grade 1, except for alopecia, fatigue, or other conditions deemed clinically insignificant by the investigator); 3.Relapsed MM patients with peripheral neuropathy (PN) = Grade 2 or Grade 1 with pain; 4.Major surgery, radiation therapy, infection requiring systemic antibiotics, or other serious infections within 14 days after enrollment; 5.Comorbid high-risk plasma cell leukemia (peripheral plasma cells = 20%); 6.Patients with mental disorders, comprehension impairments, or other reasons that render them unable to control their own behavior; 7.Pregnant or breastfeeding women, and patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial. If the patient is male, they must agree to take appropriate contraceptive measures during the study and after the last cycle of the study drug; 8.Diagnosis or treatment of another malignant tumor within 2 years prior to enrollment; 9.HIV-infected individuals (HIV antibody positive); 10.Participation in another clinical trial within 30 days after the start of this trial and throughout the entire trial period; 11.Patients deemed by the investigator to be unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month minimal residual disease negativity rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamic changes in MRD;Objective response rate (ORR);Progression-free survival (PFS);Complete response rate (CR); | — |
Countries
China
Contacts
Public ContactWeiwei Tian
Shanxi Bethune Hospital
Outcome results
None listed