Multiple myeloma
Conditions
Interventions
Experimental group:BAD (Bortezomib for Injection + Doxorubicin Liposome + Dexamethasone) regimen.
Control group:BAT ((Bortezomib for Injection Dexamethasone) regimen-based three-drug regimen.
Sponsors
Department of Hematology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged over 18 years. 2. According to the diagnostic criteria of IMWG, patients with multiple myeloma initially diagnosed and CPC positive in peripheral blood were untreated. 3. The physical condition of ECOG was less than 3 points. 4. High-sensitivity serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) for fertile women must be negative at screening. 5. Fertile women must comply with the following requirements: Subjects must agree to use an efficient contraceptive method (the annual failure rate of continuous and correct use is less than 1%) and to continue using an efficient contraceptive method for at least 100 days from the signing of the informed consent (ICF) to the acceptance of BAD infusion. Efficient contraceptive methods include: non-user-dependent methods: 1) implantable progesterone contraceptives that inhibit ovulation; 2) intrauterine device (IUD); intrauterine hormone release system; 3) vasectomy of sexual partners; user-dependent methods: 1) compound hormone contraceptives that inhibit ovulation: oral, vaginal and percutaneous administration; 2) contraceptive hormones that inhibit ovulation. Drugs (oral or injection). 6. In addition to effective contraceptive methods, male subjects should: at least 100 days after signing ICF to BAD, they must agree to use barrier contraception (for example, condoms to kill foam / gel / film / emulsion / suppository ), and pregnant women to use condoms when having sexual life; women and men must agree to study during the study period. No egg (oocyte, oocyte) or sperm should be donated within 100 days after receiving LCAR-B38M cytokine infusion. Note: Hormone contraceptives may interact with research treatment to reduce the contraceptive effect. 7. Subjects must sign the ICF to show that they understand the purpose and procedure of the study and are willing to participate in the study. Informed consent must be obtained prior to the start of any examination or procedure related to the study but not to the standard treatment of the subject's disease. 8. Taboos and restrictions that are willing and able to comply with the provisions of this programme.
Exclusion criteria
Exclusion criteria: 1. MM patients who have received any treatment. 2. Invasive malignant tumors other than multiple myeloma have been diagnosed or treated, except for malignant tumors that have undergone radical treatment and no known active diseases within 3 years or adequately treated non-melanoma skin cancer. 3. The following cardiac diseases occurred: New York Heart Association (NYHA) stage III or IV congestive heart failure; myocardial infarction or coronary artery bypass grafting (CABG) less than 6 months before admission; clinically significant ventricular arrhythmia, or history of syncope with unknown causes, non-vasovagal or non-dehydration-induced; History of severe non-ischemic cardiomyopathy; Assessment of cardiac function by echocardiography or multi-gate circuit detection (MUGA) scans (less than 8 weeks before single blood component collection) Loss (LVEF < 45%). 4. Systemic corticosteroid therapy with a dose greater than 5 mg/day prednisone (or other corticosteroids of equivalent dose) was given within 2 weeks before BAD. 5. Stroke or convulsion occurred within 6 months before signing ICF. 6. Human immunodeficiency virus (HIV) is positive in serum. 7. Hepatitis B infection as defined in the guidelines of the American Society of Clinical Oncology (ASCO). If the infection status is unknown, the infection status should be determined quantitatively. 8. Patients with hepatitis C (positive anti-HCV antibody or HCV-RNA quantitative test results) or known history of hepatitis C. 9. Oxygen inhalation is needed to maintain adequate oxygen saturation. 10. Severe underlying diseases, such as: evidence of severe active viruses, bacterial infections or uncontrolled systemic fungal infections; history of active autoimmune diseases or autoimmune diseases within three years; and clear clinical evidence of dementia or mental changes. 11. It is not conducive for subjects to receive or tolerate planned treatment in research centers, to understand any problems with informed consent, or to participate in studies that are not in the best interests of the subjects (such as impairing health), or to any situation that may prevent, restrict or confuse the assessment provided for by the research programme. 12. Female participants who were pregnant, breast-feeding or planned to become pregnant during or within 100 days after the treatment of the study. 13. Male subjects with fertility plans who participated in the study or received treatment for 100 days. 14. Major operations were performed within 2 weeks before BAD, or during the study period or within 2 weeks after treatment. (Note: Subjects planning to undergo local anesthesia surgery may participate in this study.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;VGPR;Type, degree and incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLi Zhang
West China Hospital, Sichuan University
Outcome results
None listed