multiple myeloma with plasmacytoma
Conditions
Interventions
Mitoxantrone liposomes combined with VPD/KPD regimen treatment group:NA
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Multiple myeloma patients who aged 18 to 80 years with plasmacytoma (meeting the IMWG diagnostic criteria). 2. Pathologically confirmed plasma cell tumor. 3. ECOG score 0-2. 4. Plasmacytoma has measurable indicators: = 0.5 cm; 5. Sign the written informed consent form.
Exclusion criteria
Exclusion criteria: . Patients with grade II or higher heart disease (including grade II) were identified according to the New York Heart Association (NYHA) score. 2. Subjects who have used the total cumulative dose of doxorubicin = 400 mg/m^2, the total cumulative dose of epirubicin = 750mg/m^2, and the total cumulative dose of pirarubicin = 800mg/m^2 or the previous application of anthracyclines caused cardiac disease. 3. Severe abnormalities in the function of important organs such as lungs, liver, and kidneys (cardiac ejection fraction is less than 50%, and carbon monoxide dispersion capacity caused by chronic respiratory diseases is less than 50% of the expected value). 4. The toxicity of previous chemotherapy did not return to baseline levels. 5.PN = grade 2 or grade 1 with pain. 6. Major surgery, radiation therapy, infections requiring systemic antibiotics, or other serious infections within 14 days of enrollment. 7. Central nervous system involvement. 8. Plasma cell leukemia (peripheral plasma cells > 2.0 x 10^9/L or > 20%). 9. IgM (immunoglobulin M) subtype MM. 10. Those with mental illness, impaired comprehension, or other reasons who are unable to control themselves. 11. Pregnant or lactating women and patients of childbearing age who refused to use appropriate contraception during the course of this trial. If the patient is male, refuse to use adequate contraception or donate semen during the study period and for 3 months after receiving the last cycle of drug study. 12. Diagnosed or treated another malignancy within two years prior to enrollment. 13. Those who are allergic to mitoxantrone liposomes, bortezomib, lenalidomide or more severe allergies. 14.HIV infected (HIV positive). 15. Active hepatitis B and C infection (hepatitis B virus surface antigen positive and/or hepatitis B core antibody positive and hepatitis B virus DNA exceeding 1x10^3 copies/mL; hepatitis C virus RNA exceeding 1x10^3 copies/mL); 16. Participate in another clinical trial 30 days after the start of the trial and throughout the duration of the trial. 17. The investigators determined that the patients were not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival(PFS);Overall Survival(OS);Duration of Overall Response(DOR);TTNT;Partial Response (PR);Very Good Partial Response (VGPR);Complete Response (CR);stringent Complete Response (sCR);Rate of Minimal Residual Disease (MRD); | — |
Countries
China
Contacts
Public ContactAijun Liu
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed