Bozzolo's disease
Conditions
Interventions
case group:Phendamostin combined pomadomide and dixamison
Sponsors
Qingdao Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old; 2. The diagnostic criteria listed in the 2020 China Guidelines for the Diagnosis and Treatment of multiple myeloma to evaluate patients with multiple myeloma with measurable lesions; 3. The front line has only received front-line treatment and disease progress (previous treatment or abandoned the use of denolamine due to personal reasons), recurrence accompanied by extrtramullary lesions, including bone-related plasma cell tumor, soft tissue plasma cell tumor and special site plasma cell tumor; 4. ECOG =: 2 points, with an expected life period of more than 3 months; 5. There are no serious organic lesions in the main organs (except for the renal insufficiency caused by the disease), and meet the requirements of the following laboratory examination indicators (within 7 days prior to treatment): (1) Upper normal limit of total bilirubin = (of the same age group) is 1.5 times; (2) Upper normal limit of AST (AST) and glutamate (ALT) = (of the same age); (3) Upper normal value of myocardial enzyme <(of same age); (4) Heart ejection fraction was measured by cardiac ultrasound (ECHO) within the normal value range. 6. Men or women who are not pregnant or breastfeeding and are likely to give birth agree to adopt appropriate methods of contraception within 4 weeks before treatment, during treatment, during the suspension of medication and within 4 weeks after the end of treatment; 7. Follow-up conditions exist. Patients understand the characteristics of the disease and voluntarily joined the study program for treatment and follow-up; 8. Informed consent form was signed. Informed consent form is signed by the patient himself or the immediate family members. From the consideration of the patient's condition, if the patient himself signs and is not conducive to the treatment of the condition, then the legal guardian or the immediate family member will sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Active hepatitis B, hepatitis C, and other acquired, congenital immunodeficiency diseases; 2. According to the definition of the NCAS General Naming Standard for Adverse Events (NCI CTCAE) version 4.0, the baseline has terminal neuropathy or neuralgia of level 2 or above; 3. Serious thrombotic events exist before the treatment; 4. Patients combined with uncontrolled or severe cardiovascular diseases, including myocardial infarction within 6 months before initiation, grade heart failure defined by the New York Society of Cardiology (NYHA), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloid degeneration; 5. Those undergoing major surgery within 30 days before group entry; 6. Abnormal epilepsy, dementia and other mental conditions requiring medication who fail to understand or comply with the study protocol; 7. According to the program or the judgment of the researcher, the patient suffering from serious physical illness or mental illness may interfere with the participation in the clinical research; 8. Substance abuse, medical, psychological or social conditions that may interfere with participants in research or evaluation of the outcome; 9. Patients currently undergoing other experimental drug treatment; 10. The researchers are not suitable for participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;duration of response;Progression-Free-Survival;overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhong Yuping
Chia Tai Tianqing Pharmaceutical Group Co. LTD
Outcome results
None listed