Plasma cell malignancies
Conditions
Interventions
experimental group:Precontional regimen
control group:Precontional regimen
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 18 to 70 years, male and femaleVoluntary participation in the clinical trials and sign the informed consent; 2. Types of plasm cell tumors included: Multiple myeloma; Amyloidosis; POEMS syndrome; MGUS that needs treatment; 3. Patients with BCMA+ tumor; 4. patients who are with relapsed disease after chemotherapy or hematopoietic stem cell transplantation (HSC); or patients are voluntary to accept anti-BCMA CAR-T cell therapy as the first-line therapy; 5. ECOG score 0 or 1; 6. Estimated survival of >= 12 weeks; 7. Multiple organ function assessment: 1) Blood routine: N >= 1.0 x 10^9/L; Hb >= 60 g/L; plt >= 40 x 10^9/L (when BM positive) PLT>= 40 x 10^9/L(when BM negative); 2) Aspartate transaminase-alanine transaminase ratio = 3.0 mmol/LCa >= 2.0 mmol/L Mg >= 0.5 mmol/L; 5) Fbg>=1.0g/L APTT <= ULN+10s PT <= ULN+3s; 8. providing valid diagnostic documents or bone marrow examination before treatment, and to receive bone marrow or effective examination after treatment; 9. Women of childbearing age and men with reproductive abilities were required to use one of the following effective contraception measures throughout the study and within 90 days of interruption of treatment: abstinence, double barrier contraceptive methods, intrauterine devices, The use of hormonal contraceptives began at least three months before the first dose; 10. Male subjects were not allowed to donate sperm from the beginning of treatment until 90 days after the treatment was stopped; 11. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Past treatment history: 1) undergone HSCT or immunosuppressive treatment following HCST within 2 months; 2) undergone chemotherapy, immunotherapy, radiotherapy or major surgery within four weeks; 3) undergone Live vaccines within four weeks; 4) undergone clinical trials or are participating in other clinical trials within 4 weeks; 2. Medical History and Operation History: 1) Patients with plasma cell tumors with central nervous system invasion; 2) Hypertension and drug treatment can not obtain good control(blood pressure & GT; 140/90 mmHg); 3) Doppler ultrasound evaluation: LVEF= 1.00x10^3 copies/ml;Anti-HCV+ with HCV DNA is positive; 7) severe electrolyte disorders; 8) Patients with a clear tendency to gastrointestinal bleeding include the following: there is a localized active ulcer lesion, and latent blood in the stool(+ +); 2 months in the history of black stool, vomiting blood; The researchers believe there may be a major gastrointestinal hemorrhage; 9) People with a history of organ transplants; 10) unfit for clinical trials because of other acute severe or chronic medical or psychological conditions; 11) Pregnancy and nursing females; Or females &males with fertility plans1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactJianfeng Zhou
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed