Bozzolo's disease
Conditions
Interventions
Group A:Selinexor combined with Pomalidomide and dexamethasone
Sponsors
Qingdao Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years; 2.Diagnostic criteria listed in the diagnosis and treatment of multiple myeloma in the 2020 Guidelines of China to evaluate patients with multiple myeloma with measurable lesions; 3.Image of central involvement (cranial MRI) diagnosis or flow discovery of monoclone; 4.ECOG <= 2, estimated survival exceeds 3 months; 5.No active infectious diseases; 6.The main organs do not have serious organic lesions (except for renal insufficiency caused by the disease), and meet the requirements of the following laboratory examination indicators (within 7 days before treatment); (1)The upper normal value of total bilirubin (of the same age group) is 1.5 times; (2)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2 times the upper limit of normal (for the same age group); (3)The upper limit of myocardial enzyme is less than 2 times the normal value (of the same age group); (4)Heart ejection fraction (ECHO) measurement by cardiac ultrasound is within the normal range; 7.Men or women who are not pregnant or breastfeeding and may have given birth agree to adopt appropriate contraception at 4 weeks before treatment, during suspension of medication and within 4 weeks after the end of treatment; 8.Follow-up conditions are available. Patients understood the characteristics of the disease and volunteered to join the study protocol for treatment and follow-up; 9.Informed consent form has been signed. Informed consent was signed by the patient himself or his immediate family member. From the consideration of the patient's condition, if the patient's own signature is not conducive to the treatment of the condition, then the legal guardian or the patient's immediate family member will sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with acquired or congenital immune deficiency diseases; 2.According to the General Nomenclature Standard for Adverse Events (NCI CTCAE) version 4.0 of the National Cancer Institute, the baseline has a terminal neuropathy or neuralgia with grade 2 or above; 3.Severe thrombotic events exist before treatment; 4.Patients have uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months prior to enrollment, III-IV heart failure defined by the New York Society of Cardiology (NYHA), uncontrolled angina pectoris, clinically significant cardiac pericardial disease, or cardiac amyloidosis; 5.Patients undergoing major surgery within 30 days before enrollment; 6.People with epilepsy, dementia and other mental conditions requiring medical treatment can not understand or follow 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 of the clinical research; 8.Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or with the evaluation of the study results; 9.Patients currently undergoing other experimental drugs; 10.The researcher thinks it is not suitable for the participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Duration of Response;Complete Response Rate;Safety; | — |
Countries
China
Contacts
Public ContactYuping Zhong
Qingdao Municipal Hospital
Outcome results
None listed