relapsed myeloma (MM) with plasmacytoma
Conditions
Interventions
Aponermin group:NA
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years with relapsed and relapsed multiple myeloma(MM) who meet the IMWG diagnostic criteria. 2. Pathological confirmation shows that it is a plasmacytoma. 3. CT/MRI can evaluate plasmacytoma >= 1cm, with a quantity greater than 1. 4. ECOG score 0-2. 5. Patients are able to understand the various changes and treatment options during and after the treatment process, and have good compliance with the received treatment and follow-up. 6. Sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe functional abnormalities in important organs such as the heart, lungs, and liver (heart ejection fraction below 50%, carbon monoxide diffusion capacity caused by chronic respiratory diseases below 50% of the expected value, serum bilirubin levels exceeding 2mg/dl, or ALT or AST levels exceeding 2.5 times the upper limit of normal), and glomerular filtration rate less than 30ml/min. 2. The toxicity of previous chemotherapy in relapsed MM patients has not returned to baseline levels (= grade 2 or grade 1 accompanied by pain. 4. Major surgery, radiation therapy, infections requiring systemic antibiotic treatment, or other severe infections within 14 days after enrollment. 5. Merge high-risk plasma cell leukemia (peripheral plasma cells >= 20%). 6. Individuals with mental illnesses, comprehension disorders, or other reasons who are unable to control themselves. 7. Pregnant or lactating women, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial. If the patient is male, they refuse to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of medication research. 8. Diagnosed or treated with another malignant tumor within 2 years prior to enrollment. 9. Individuals with allergies or severe allergies to ingredients such as Epenemine, Cafizomide, and Thalidomide. 10. HIV infected individuals (HIV antibody positive); 11. Participate in another clinical trial 30 days after the start of the trial and throughout the entire trial period; 12. The researcher determines that patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS;Minimal Residual Disease, MRD;Time To Next Treatment, TTNT;Duration of Response, DOR;Overall Survival, OS;Complete Response, CR;Stringent Complete Response, sCR;Very Good Partial Response, VGPR; | — |
Countries
China
Contacts
Public ContactAijun Liu
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed