Relapsed/refractory multiple myeloma
Conditions
Interventions
Epnaimin Observation Group:None
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with relapsed and refractory MM who are older than 18 years old (meet the diagnostic criteria of IMWG). 2. ECOG score 0-2. 3. Have measurable disease, defined as follows: serum M-protein >= 0.5 g/dL, or urine M-protein >= 200 mg/24 hours, and patients without measurable serum or urine M-protein must have serum free light chain (sFLC) > 100 mg/L (involved light chain) and abnormal kappa/lambda ratio (SFLC kappa/lambda ratio 1.65). 4. CT/MRI can assess >= 1 cm of plasmacytoma, the number >1. 5. Patients can understand the various changes during and after treatment and the choice of treatment methods, and have good compliance with the planned treatment and follow-up. 6. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Relapsed and refractory MM with more than five lines. 2. Serious abnormalities in the function of important organs such as the heart, lungs and liver (cardiac ejection fraction less than 50%, carbon monoxide diffusion capacity caused by chronic respiratory diseases is less than 50% expected, serum bilirubin level exceeds 2mg/dl, or ALT or AST level is higher than the upper limit of normal by 2.5 times), and blood creatinine clearance is less than 50ml/min). 3. The toxicity of previous chemotherapy in patients with recurrent MM has not returned to baseline level (=grade 2 or grade 1 with pain. 5. Major surgery, radiation therapy, infection requiring systemic antibiotic therapy or other serious infection within 14 days of enrollment. 6. Plasma cell leukemia (peripheral plasma cells>=20%). 7. Those who have mental illness, comprehension disorder or other reasons that cannot control themselves. 8. Pregnant or lactating women and patients of childbearing age who refuse to take adequate contraception during the course of this trial. If the patient is male, refusal to use an adequate method of contraception or donate semen during the study and for 3 months after receiving the last cycle of the drug study. 9. Diagnosed or treated another malignancy within 2 years prior to enrollment. 10. Those who are allergic to eprenamin, carfizomib and other ingredients or have severe allergies. 11. HIV-infected individuals (HIV antibody positive). 12. Participation in another clinical trial 30 days after the start of the trial and throughout the trial. 13. Patients who are judged by the investigator to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Next Treatment (TTNT);Minimal Residual Disease Negativity Rate (MRD?);Complete Response Rate (CR);Very Good Partial Response Rate (VGPR);Stringent Complete Response Rate (sCR);Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactAijun Liu
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed