Phase
Condition
Multiple Myeloma
Lymphoproliferative Disorders
Leukemia
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient had multiple myeloma (according to the updated IMWG diagnosticcriteria)Active (symptomatic) myeloma
Refractory and recurrent multiple myeloma Refractory definition: 1) treated with atleast second-line bortezomib or lenalidomide 2) determined by the clinician Definitionof recurrence: refer to NCCN clinical guidelines for multiple myeloma (2016. V2),including recurrence after transplantation.
Age: 18 to 80 years old;
The expected survival time was more than 3 months;
ECoG score 0-2 (refer to Annex 2)
Hemoglobin (HB)≥80g/L; absolute neutrophil count (ANC)>1×10^9/L; plateletcount(PLT)≥50×10^9/L. Those who voluntarily participated in the experiment and signed informed consent.
Exclusion
Exclusion Criteria:
High risk organ involvement patients: tumor invasion of central nervous system,gastrointestinal tract,lung,pericardium,one of the major vessels;
Those who have graft-versus-host reaction and need to use immunosuppressants, or whohave autoimmune diseases;
Chemotherapy or radiotherapy was used within 3 days before blood collection;
Patients who used systemic steroids within 5 days before blood collection (exceptthose who have recently or are currently using inhaled steroids);
The patients who used drugs to stimulate the production of bone marrow hematopoieticcells within 5 days before the blood collection period;
Those who have previously used any gene therapy products;
History of epilepsy or other central nervous system diseases;
New York Heart Association (NYHA) grade III or above (refer to Annex 3) (for patientswith heart disease, this assessment is required);
Creatinine > 1.5 times normal upper limit, ALT / AST>3 times normal upper limit orbilirubin >2 times normal upper limit;
Active hepatitis B or hepatitis C virus, HIV or other uncured active infections;
Pregnant or lactating women;
Those who suffer from other uncontrolled diseases are not suitable to join the study;Any situation that the researchers believe may increase the risk of subjects orinterfere with the test results.
Study Design
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100005
ChinaActive - Recruiting
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