Multiple Myeloma
Conditions
Interventions
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female participants aged >=18 and 12 weeks. 3.Participants must have a confirmed diagnosis of multiple myeloma. 4.Refractory or relapsed multiple myeloma patients 5.ALT/AST = 50%). 8.Voluntarily participated in the trial of CAR-T for the treatment of multiple myeloma. 9.Blood was collected intravenously and no other contraindications for apheresis. 10.Informed Consent/Assent: All subjects have the ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Participants in pregnancy or breast-feeding period; Planning pregnancy within 6 months; 2.HIV or active TB infected; 3.Active hepatitis B or hepatitis C infection; 4.Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 5.Participants with abnormal vital signs or could not cooperate with inspectors; 6.History of mental disorders; 7.Highly allergic constitution or severe allergies, especially allergic to IL-2; 8.Systemic infection or serious infections should be local anti-infection treatment; 9.With heart, lung, brain, kidney and other important organ dysfunction; 10.Presence of severe autoimmune disease; 11.Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Progression free survival;Overall survival;Minimal residual disease;Safety; | — |
Countries
China
Contacts
Public ContactKailin Xu
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed