Multiple Myeloma
Conditions
Interventions
Experimental group:Celinisol + bortezomib + lenalidomide + dexamethasone
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed high-risk MM patients aged 18-70 years (meeting IMWG diagnostic criteria); 2. ECOG score 0-2; 3. One of the characteristics of high-risk MM: two high-risk genetic abnormalities in genetics (FISH); myeloma with peripheral plasma cells (5-19%), elevated lactate dehydrogenase, and plasmacytoma; 4. With measurable disease, which is defined as follows: serum M protein >= 0.5 g/dL, or urine M protein >= 200 mg/24 hours, or 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 1.65. Plasmacytoma >= 1 cm that can be assessed by CT/MRI; 5. Patients can understand various changes during and after treatment and the choice of treatment methods, and have good compliance with planned treatment and follow-up; 6. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Non-high-risk MM; 2. Relapse MM; 3. Severely abnormal functions of the heart, lungs, liver and other important organs (cardiac ejection fraction is less than 50%, carbon monoxide dispersion capacity due to chronic respiratory diseases is less than 50% of the expected value, serum creatinine level is more than 2 mg/dl, or ALT or AST level is 2.5 times higher than the upper limit of normal); 4. Major surgery, radiation therapy, infections requiring systemic antibiotics or other serious infections within 14 days after enrollment; 5. Plasma cell leukemia (peripheral plasma cells > 2.0 x 10^9/L or > 20%); 6. IgM (Immunoglobulin M) subtype MM; 7. Those who are unable to control themselves due to mental illness, comprehension disorder or other reasons; 8. Pregnant or lactating women and patients of childbearing age who refused to use appropriate contraceptive methods during the course of this study. If the patient is male and refuses to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study; 9. Diagnosis or treatment of another malignant tumor within 2 years prior to enrollment; 10. People who are allergic to Selinisol, bortezomib, lenalidomide or have severe allergies; 11. Hiv-infected persons (HIV-antibody positive); 12. Participate in another clinical trial 30 days after the start of the trial and throughout the trial period; 13. The researchers judged the patients who were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total effective rate;Progression-free survival time, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial relief;safety;Overall survival time, OS; | — |
Countries
China
Contacts
Public ContactWenming Chen
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed