multiple myeloma
Conditions
Interventions
Sponsors
Qingdao Municipal Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: =65 years old; 2. Patients were required to determine the diagnosis of MM based on the following criteria Key criteria 1) Plasmacytoma was confirmed by biopsy 2) Bone marrow plasmacytosis (plasma cells > 30%) 3) serum monoclonal immunoglobulin spike IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL; Kappa or ? light chain excretion was greater than 1 g/ day as determined by 24-hour urinary protein electrophoresis Secondary Criteria 1) Bone marrow plasmacytosis (10% to 30% plasma cells) 2) Monoclonal immunoglobulin is present but to a lesser extent than specified by the main criteria 3) osteolytic lesions 4) IgM < 50 mg/dL, IgA < 100 mg/dL, IgG < 600 mg/dL Any of the following sets of criteria will confirm the diagnosis of multiple myeloma ? Meets any two of the main criteria ? Major criterion 1 plus minor criterion 2,3 or 4 ? Major criterion 3 plus minor criterion 1 or 3 ? Minor criteria 1,2,3 or 1,2, 4 3, ECOG=2, predicted survival time more than 3 months; 4. No active infectious diseases; 5. No serious organic lesions in major organs (except renal insufficiency caused by the disease), and meet the requirements of the following laboratory tests (within 7 days before treatment) : 1) Total bilirubin = 1.5 times the upper limit of normal (for the same age group); 2) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2 times the upper limit of normal (for the same age); 3) cardiac enzymes < 2 times the upper limit of normal; 4) The ejection fraction measured by echocardiography (ECHO) was within the normal range. 6, not pregnant, not breastfeeding, may give birth to male or female consent to take this product during the period and within 90 days after stopping treatment must use highly effective contraceptive measures; 7. There are follow-up conditions. The patients knew the characteristics of the disease and voluntarily joined the study protocol for treatment and follow-up. 8. Informed consent has been signed. Written informed consent was obtained from the patients or their immediate family members. In view of the patient's condition, if the patient's signature was not conducive to the treatment of the disease, the legal guardian or the patient's immediate family members would sign the informed consent.
Exclusion criteria
Exclusion criteria: 1, Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired, congenital immunodeficiency diseases; 2, Grade 2 or higher terminal neuropathy or neuralgia at baseline as defined by the National Cancer Institute Common Nomenclature Criteria for Adverse Events (NCI CTCAE) version 4.0; 3, Presence of a serious thrombotic event prior to treatment; 4, Hepatic insufficiency (ALT and AST =2 times the upper limit of normal); 5, Total bilirubin = 1.5 times the upper limit of normal value; 6, Patients with comorbid uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months prior to enrollment, class III-IV heart failure as defined by the New York Heart Association (NYHA), uncontrolled angina pectoris, clinically significant pericardial disease, or cardiac amyloidosis; 7, Those who underwent major surgery within 30 days prior to enrollment; 8, Those with epilepsy, dementia and other abnormal mental conditions requiring medication who are unable to understand or comply with the study protocol; 9. Patients with serious physical or mental illnesses that, in the judgment of the protocol or the investigator, are likely to interfere with participation in this clinical study; 10, Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or the evaluation of study results; 11, Patients undergoing treatment with other experimental drugs; 12, Pregnant or lactating women; 13, Persons deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate,CR;Duration of Response,DOR;Progression-free Survival,PFS;Overall survival,OS;Safety; | — |
Countries
China
Contacts
Public ContactYuping,Zhong
Qingdao Municipal Hospital
Outcome results
None listed