Anemia Associated with Multiple Myeloma
Conditions
Interventions
Control group:Placebo
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old 2. Newly diagnosed multiple myeloma 3. During the screening period, the patient's average hemoglobin value over the last 3 measurements is Hb <8 g/dL 4. The subject voluntarily participates and voluntarily signs the informed consent form (ICF) approved by the Ethics Committee (EC).
Exclusion criteria
Exclusion criteria: 1. Renal insufficiency, with serum creatinine >=177 µmol/L or creatinine clearance =40 mL/min; 2. Concomitant nutritional anemia, such as iron deficiency anemia or megaloblastic anemia; 3. Known medical history of conditions that may cause anemia, including myelodysplastic syndrome (MDS), thalassemia, sickle cell anemia, pure red cell aplasia, hemochromatosis, hemosiderosis, thrombotic disorders, or hypercoagulable state; 4. Any clinically significant infection or evidence of active underlying infection; 5. Positive for HIV, HBsAg, or anti-HCV antibody; 6. Chronic liver disease; 7. Abnormal liver function, with ALT and AST levels >1.5 × upper limit of normal (ULN); 8. Unstable cardiovascular or cerebrovascular disease; 9. Uncontrolled hypertension; 10. New York Heart Association (NYHA) Class III or IV congestive heart failure; 11. Myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event within 52 weeks prior to intervention; 12. Clinically significant gastrointestinal bleeding; 13. Life expectancy <12 months; 14. Blood transfusion within 12 weeks before intervention or anticipated need for transfusion; 15. Treatment with erythropoiesis-stimulating agents (ESAs) within 4 weeks before randomization; 16. Intravenous iron supplementation during screening or unwillingness to discontinue IV iron therapy; 17. Pregnant or lactating women; 18. History of other malignancies, except: cancers considered cured or in clinical remission for =5 years, surgically resected basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ at any site; 19. Chronic inflammatory diseases that may impair erythropoiesis (e.g., rheumatoid arthritis, systemic lupus erythematosus); 20. Planned elective surgery during the study period that may result in significant blood loss; 21. Androgen therapy, deferoxamine, or deferiprone treatment within 12 weeks before intervention; 22. Current participation in another clinical trial or residual interference from prior clinical studies; 23. Other medical conditions that may interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Iron metabolism-related parameters (transferrin saturation, total iron-binding capacity, ferritin, hepcidin) and EPO levels;Health-related quality of life (HRQoL) score;Safety; | — |
Countries
China
Contacts
Public ContactZhen Cai
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed