Multiple Myeloma
Conditions
Interventions
Intervention group:Roxadustat
Control group:None
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Incipient multiple myeloma; 3. Stage 3, Stage 4, Stage 5 renal insufficiency (eGFR < 60ml/min·1.73m^2) without dialysis; 4. During the screening period, the mean Hb of the last 3 times was < 10g/dL; 5. Patients did not receive erythropoietic stimulants for at least 4 weeks before randomization; 6. ALT and AST levels were less than or equal to 1.5 times the upper limit of normal value, and bilirubin levels were normal; 7. Patients voluntarily participate and sign the informed consent form (ICF) approved by the Ethics Committee (EC).
Exclusion criteria
Exclusion criteria: 1. Evidence of any clinically significant infection or active underlying infection; 2. HIV, HBsAg or anti-HCVAB positive; 3. Chronic liver disease; 4. Hypertension is not controlled; 5. New York Heart Association Class ? or ? congestive heart failure; 6. Myocardial infarction, acute coronary syndrome, stroke, epilepsy, or thromboembolic events occurred within 52 weeks prior to intervention; 7. Gastrointestinal bleeding in clinical sense; 8. Life expectancy 2.0g/ day, or > 500mg/ time, once every 6 hours for more than 3 days; 18. There were anticipated elective surgeries during the study period that might result in significant blood loss; 19. Iron removal therapy such as androgen, iron amine and iron ketone was received within 12 weeks prior to intervention; 20. Be participating in other clinical trials, or has participated in previous clinical studies with residual interference; 21. Other medical conditions that may interfere.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| hepcidin;transferrin;serum ferritin;erythropoietin;serum iron;life quality; | — |
Countries
China
Contacts
Public ContactCai Zhen
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed