multiple myeloma
Conditions
Interventions
treatment group:Selinexor+bortezomib+lenalidomide + 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. Patients had any of the following risk factors: (1) Extramedullary lesions: Patients with extramedullary lesions of the skin, liver, lung, central nervous system, lymph nodes, or other tissues, or extramedullary lesions of the parabony soft tissues; (2) Plasma cell leukemia: the proportion of neoplastic plasma cells in peripheral blood leukocytes > 5%; The absolute value of neoplastic plasma cells in peripheral blood was > 2x10^9/L; (3) Cytogenetic high risk: according to mSMART 3.0, high risk is defined as meeting at least one of the following criteria: t (4; 14), t (14; 16), t (14; 20), 17p- or 1q +; 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) The upper limit of the normal value of glutamase (AST) and alanine (ALT) (of the same age); (3) Two times the upper normal limit of myocardial enzyme < (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 active hepatitis B (HBV), hepatitis C (HCV), and other acquired and 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. Liver insufficiency (upper limit of ALT and AST); 5. The upper limit of the total bilirubin normal value is 1.5 times; 6. Patients have uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months prior to enrollment, grade-grade heart failure defined by the New York Society of Cardiology (NYHA), uncontrolled angina pectoris, clinically significant cardiac pericardial disease, or cardiac amyloidosis; 7. Patients undergoing major surgery within 30 days before enrollment; 8. People with epilepsy, dementia and other mental conditions requiring medical treatment can not understand or follow the study protocol; 9. 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; 10. 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; 11. Patients currently undergoing other experimental drugs; 12. Pregnant or lactating women; 13. The researcher thinks it is not suitable for the participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, Objective Remission Rate;minimal residual disease (MRD) negative rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| CR, Complete Response;Safety; | — |
Countries
China
Contacts
Public ContactYuping Zhong
Qingdao Municipal Hospital
Outcome results
None listed