Multiple myeloma
Conditions
Interventions
therapy group:Ixazomib 4 mg orally
pomalidomide 4 mg orally
dexamethasone 40 mg orally [for patients over 75 years old, the dose of dexamethasone is reduced to 20 mg, and the cycle remains unchanged
28 days is a cycle.
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. >= 18 years old; 2. Patients with multiple myeloma are clearly diagnosed, and the diagnostic criteria are the Chinese guidelines for the diagnosis and treatment of multiple myeloma (revised in 2020); 3. Patients diagnosed with multiple myeloma by cytomorphology, flow cytometry and other examinations have poor efficacy after receiving standard treatment regimens (chemotherapy regimens based on proteasome inhibitors and immunomodulatory inhibitors) (4 Patients with relapsed and refractory multiple myeloma who have not reached PR for the first time; 4. No previous treatment with ixazomib or pomalidomide; 5. Subjects of childbearing age should take effective contraceptive measures and agree to abide by all contraceptive requirements; Contraceptive Requirements: Women of childbearing potential must decide to take two reliable methods of contraception (one highly effective method of birth control - tubal ligation, IUD, hormones (pills, needles, patches, vaginal rings or implants) ) or partner's vasectomy, another effective contraceptive regimen - male's rubber or synthetic condom, diaphragm or cervical cap); unless due to hysterectomy, effective contraception is also required if there is a history of infertility in time. Men of childbearing potential must always use rubber or synthetic condoms while taking this product and for 28 days after stopping this product when having sexual contact with women of childbearing potential, even if they have had a successful vasectomy. 6. Multiple myeloma patients with measurable M protein must meet at least one of the following 3 determinations: serum M protein >= 5 g/L; urine M protein >= 200 mg/24h; in serum free light chain In the case of abnormal ratios, the level of involved free light chains is >= 100 mg/L; 7. Hematology meets the following conditions: when myeloma cells are less than 50%, ANC>= 1.0x10^9/L (including under the support of G-CSF) and PLT>= 75x10^9/L; myeloma cells When >= 50%, any ANC and PLT>= 50x10^9/L; 8. Those who can accept and can use antithrombotic drugs, such as low molecular weight heparin sodium or aspirin; 9. Physical fitness status (ECOG) score = 3 months; 10. Clearly understand the content of the trial, voluntarily participate in and complete the trial, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with allergy/intolerance to ixazomib, pomalidomide or dexamethasone; 2. Patients who are resistant to bortezomib; 3. Patients with severe cardiopulmonary insufficiency; 4. In patients with severe hepatic and renal insufficiency, ALT or AST or bilirubin exceeds the upper limit of normal by more than 3 times, and the creatinine clearance rate is less than 30 ml/min; 5. Patients with other malignant tumors (except carcinoma in situ); 6. Patients with severe bacterial or viral infection, such as HIV or HBV, HCV, etc.; 7. Patients with active new thrombosis or unwilling to undergo antithrombotic therapy; 8. Patients with peripheral neuropathy >= grade 3; 9. Women who are pregnant or breastfeeding; 10. Psychiatric patients and those with severe mental and mental illness who may potentially affect the signing of the informed consent form and the consultation and follow-up of the disease; 11. Those who have participated in other clinical trials within one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;until the next treatment time; | — |
Countries
China
Contacts
Public ContactFang Baijun
Henan Cancer Hospital
Outcome results
None listed