Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Sponsors
Cancer Hospital Affiliated to Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 18-70 years when signing informed consent 2.According to the international standard for multiple myelomahave information on medical examination proving the diagnosis of multiple myeloma. 3.Received at least 2 prior lines of treatment regimens for Relapsed or Refractory multiple myeloma, including proteasome inhibitor and immunomodulator, no efficacy more than PD; disease progression or relapsed after disease remission and refractory or no remission after treated in the last time. 4.Patients must have measurable MM as defined by at least one of the criteria below: Serum monoclonal paraprotein (M-protein) level >= 0.5 g/dL or urine M-protein level >= 200mg/24hor light chain MM without measurable disease in the serum or the urineserum immunoglobulin free light chain >= 10mg/ dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio 5.ECOG Scores: 0~1the estimated survival time was more than 3 months
Exclusion criteria
Exclusion criteria: 1.Have been diagnosed or treated with other invasive malignant tumors except multiple myeloma, except for the following cases: malignant tumors that have received radical treatment and have no known active diseases for >= 3 years before signing the informed consent; Or well treated non melanoma skin cancer, there is no evidence of disease. 2.Previously received the following anti-tumor treatment (within 21 days before component blood collection): received targeted therapy, epigenetic therapy or experimental drug treatment within 21 days or at least 5 half-life (whichever is shorter), or used invasive experimental medical devices; Received cytotoxic drug treatment, proteasome inhibitor treatment, immunomodulator treatment and radiotherapy within 14 days; 3.There are serious cardiovascular and cerebrovascular diseases: New York Heart Association (NYHA) stage III or IV congestive heart failure; Cerebrovascular accident, myocardial infarction or arrhythmia causing hemodynamic instability occurred within 6 months before signing the informed consent; Echocardiographic scan showed impaired cardiac function (LVEF < 50%); 4.Systemic corticosteroid treatment with a dose greater than 10mg/d prednisone (or other corticosteroids with equivalent dose) within 2 weeks before gonorrhea; 5.Have received allogeneic hematopoietic stem cell transplantation in 3 months for the treatment of multiple myeloma; 6.Any other condition that researcher think it is inappropriate for the subject to anticipate the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| validity; | — |
Countries
China
Contacts
Public ContactCen Hong
Cancer Hospital Affiliated to Guangxi Medical University
Outcome results
None listed