multiple myeloma
Conditions
Interventions
Case series:BDVP scheme
Sponsors
Department of Hematology, Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Make clear the diagnosis of multiple myeloma patients, and the diagnostic standard is the International Myeloma Working Group (IMWG) 2016 standard; 3. Patients with recurrent and refractory multiple myeloma; 4. The score of physical fitness status (ECOG) is = 3 months; 5. Multiple myeloma patients with measurable M protein should meet at least one of the following three determinations: 1) Serum M protein >= 5 g/L; 2) Urine M protein >= 200 mg/24h; 3) In the case of abnormal serum free light chain ratio, the level of affected free light chain >= 100 mg/L; 6. Absolute neutrophil count (ANC)>1.0 × 10^9/L, platelet count>75.0 × 10^9/L Blood transfusion is allowed if there are clinical indications 7. Two weeks (14 days) washout period is required from the last treatment (excluding dexamethasone treatment); 8. Have not been treated with Bendamustine or Pomadomide in the past; 9. No active infectious disease; 10. The main organs have no serious organic lesions (except for renal insufficiency caused by this disease), and meet the requirements of the following laboratory examination indicators (within 7 days before treatment): 1) Total bilirubin =30ml/min; 11. Subjects of childbearing age should take effective contraceptive measures and agree to comply with all contraceptive requirements; 12. Contraceptive requirements: women with fertility must decide to take two reliable contraceptive methods at the same time (one efficient contraceptive method - tubal ligation, intrauterine contraceptive device, hormone (contraceptive pill, needle, patch, vaginal ring or implant) or partner vas deferens ligation, the other effective contraceptive method - male rubber or synthetic condom, diaphragm or cervical cap); Unless due to hysterectomy, effective contraception is required even if there is a history of infertility. Men with fertility must always use rubber or synthetic condoms when taking this product and when having sexual contact with women with fertility within 28 days after stopping using this product, even if they have successfully undergone vasectomy; 13. Clearly understand the content of the test, voluntarily participate in and complete the test, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity/intolerance to bendamustine, pomalidomide, bortezomib or dexamethasone; 2. Patients with severe hepatic insufficiency, ALT or AST or bilirubin exceeding 3 times the upper limit of normal, and patients with other malignant tumors (except carcinoma in situ); 3. Patients with active replication of severe current virus (such as HBV); 4. Patients with active new thrombosis or unwilling to undergo antithrombotic therapy; 5. Patients with peripheral neuropathy >= grade 3; 6. Major surgery within 21 days before the first administration; 7. Congestive heart failure, ischemic symptoms, conduction abnormalities or myocardial infarction within the past six months; 8. Uncontrolled high blood pressure; 9. Acute active infection requiring systemic antibiotics, antiviral or antifungal drugs within 14 days before the first dose; 10. Active treatment or intervention for other malignancies, or require active treatment within 8 months after initiation of study treatment. 11. Women who are pregnant or breastfeeding; 12. Psychiatric patients and those with severe mental and mental illness who potentially affect the signing of the informed consent form and the consultation and follow-up of the disease; 13. Those who have participated in other clinical trials within one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactHui Qin
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed