Multiple Myeloma
Conditions
Interventions
Experimental group (carfilzomib):None
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. NDMM with measurable diseases suitable for transplantation: measured by serum M protein, urine M protein, serum free light chain (SFLC) and abnormal serum kappa lambda ratio (for subjects who cannot detect serum or urine M protein), or serum quantitative immunoglobulin A (glgA) (for subjects with immunoglobulin A (Ig), the disease can only be reliably measured by qlgA) 2. 18 = Age = 70 years old 3. ECOG score 0-2 4. Baseline BNP = 500 pg/mL 5. Sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1. According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II) are recognized. 2. Patients with BNP>500 pg/mL. 3. Patients with concurrent amyloidosis. 4. Subjects who have used a total cumulative dose of doxorubicin = 400 mg/m2, a total cumulative dose of epirubicin = 750 mg/m2, a total cumulative dose of pirarubicin = 800 mg/m2, or have previously used anthracycline drugs that have caused heart disease. 5. Severe dysfunction of important organs such as lungs, liver, and kidneys (heart ejection fraction below 50%, carbon monoxide diffusion ability caused by chronic respiratory diseases below 50% of expected value). 6. PN = grade 2 or grade 1 with pain. 7. Major surgery, radiation therapy, infections requiring systemic antibiotic treatment, or other serious infections within 14 days after enrollment. 8. Central nervous system involvement. 9. Plasma cell leukemia (peripheral plasma cells>2.0 × 109/L or>20%). 10. IgM (immunoglobulin M) subtype MM. 11. POEMS syndrome (multiple neuropathies, organ enlargement, endocrine disorders, monoclonal proteins, and skin changes) 12. Individuals with mental illness, comprehension disorders, or other reasons that make it difficult to control themselves. 13. 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, refuse to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study. 14. Diagnosed or treated another malignant tumor within 2 years prior to enrollment. 15. HIV infected individuals (HIV antibody positive). 16. Participate in another clinical trial 30 days after the start of the trial and throughout the entire trial period. 17. Patients deemed unsuitable for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) for 4 cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| 18 month PFS rate;18 month OS rate;Overall OR rate;MRD negative rate;1-year continuous negative rate of MRD; | — |
Countries
China
Contacts
Public ContactAijun Liu
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed