multiple myeloma
Conditions
Interventions
Case series:No
Sponsors
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must satisfy all the following criteria to be enrolled in the study: 1. Subjects diagnosed with symptomatic MM according to the 2016 IMWG guidelines achieved a partial response (PR) or better after 4 to 6 cycles of induction chemotherapy; 2. Aged 18-70 years, ECOG performance score 0-2, clinical laboratory tests 7 days before stem cell mobilization met the following criteria: (1) Cardiac function: left ventricular ejection fraction > 40% (echocardiography); (2) Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 40 ml/min/1.73m2; (4) Coagulopathy: PT and APTT < 2 times normal values; 3. The subjects and their legal principal had the desire and requirement to perform autologous hematopoietic stem cell transplantation, and signed the informed consent for clinical trials and the informed consent for the biobank of Ruijin Hospital.
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from enrollment: 1. Serious underlying condition: (1) Evidence of severe active viral, bacterial, or uncontrolled systemic fungal infection; (2) Active autoimmune disease or history of autoimmune disease within 3 years; (3) There was clear clinical evidence of dementia or altered mental status; 2. Stroke or seizure within 6 months prior to signing the ICF; 3. Had received hematopoietic stem cell transplantation (autologous/allogeneic) or other cell therapy; 4. HIV virus test is positive; 5. Patients with active infectious stage of HBV and HCV; 6. Diagnosed with or treated for another aggressive malignancy other than multiple myeloma with the following exceptions: (1) Malignancy who had undergone radical therapy and had no known active disease for >= 2 years before enrollment; (2) Adequately treated non melanoma skin cancer, now without evidence of disease; 7. Those who are judged by the investigator to be unsuitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Median time of granulocyte engraftment and engraftment rate;Median time of platelet engraftment and engraftment rate;Rates of minimal residual disease (MRD) negativity before and after autologous hematopoietic stem cell transplantation (ASCT);incidence rate of engraftment Syndrome; | — |
Countries
China
Contacts
Public ContactJianqing Mi
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed