Multiple myeloma
Conditions
Interventions
Experimental group:Bortezomib /lanaduramide /dexamethasone (VRD) regimen was induced in patients with newly diagnosed multiple myeloma
Sponsors
Center for Cancer Prevention and Treatment, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~ 78 years; 2. The diagnostic criteria listed in the Chinese guidelines for the diagnosis and treatment of multiple myeloma in 2017 (see annex 1) evaluate patients with multiple myeloma with initially diagnosed activity (symptomatic) and measurable lesions; 3. ECOG 10.0g /L was detected by serum protein electrophoresis or immunoglobulin electrophoresis. or 2) >, 1g/ 24h, protein M in urine; or 3) bone marrow biopsy and/or biopsy increased bone marrow plasma cells by > 30%; or 4) in the absence of renal failure, the upper limit of normal value of serum free light chain > 2 (ULN) 5. No active infectious diseases; 6. The main organs have no serious organic lesions (except renal insufficiency caused by the disease), which meet the requirements of the following laboratory examination indicators (within 7 days before treatment): 1) total bilirubin <= 1.5 times the upper limit of normal value (in the same age group); 2) AST and ALT <= 3 times the upper limit of normal value (in the same age group); 3) myocardial enzymes < 2 times the upper limit of normal value (in the same age group); 4) cardiac ejection fraction was measured by echocardiography within the normal range. 7. Informed consent has been signed. Informed consent signed by the patient or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to treatment, the legal guardian or the patient's immediate family member shall sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Once received anti-myeloma treatment (excluding radiotherapy, bisphosphonates or single short-term hormone therapy [i.e., dose less than or equal to 40mg/ day, 4 days of prednisone]; Received short-term (<=14d) anti-myeloma treatment before enrollment; 2. Non-active multiple myeloma, including MGUS and smoking myeloma; 3. Amyloid lesions, severe infectious diseases (untreated tuberculosis and pulmonary aspergillosis), hiv-positive carriers, and patients with other malignant tumors; 4. Baseline stage 2 or higher terminal neuropathy or neuralgia, as defined in NCI CTCAE 4.0; 5. Severe thrombus events existed before treatment; 6. Patients with uncontrolled or serious cardiovascular disease, including 6 months before the group of myocardial infarction, New York heart association (NYHA) class defined III - IV hf, uncontrolled angina pectoris, clinically significant pericardial disease, or cardiac amyloidosis. 7. Those who received major surgery within 30 days prior to inclusion; 8. Any drug allergy involved in this experiment; 9. Epilepsy, dementia and other mental disorders that require medication and cannot understand or follow the study plan; 10. According to the protocol or the judgment of the researcher, the patient may suffer from serious physical or mental illness that may interfere with the participation in this clinical study; Substance abuse, medical, psychological or social conditions that may interfere with subjects' participation in the study or evaluation of the study results; 11. Patients receiving other experimental drugs; 12. Pregnant or nursing women; 13. Not suitable for inclusion, according to the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Very Good Partial Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Complete Response Rate;duration of response;Progression-free Survival; | — |
Countries
China
Contacts
Public ContactZhongjun Xia
Center for Cancer Prevention and Treatment, Sun Yat-Sen University
Outcome results
None listed