Multiple myeloma associated anemia
Conditions
Interventions
Control group:Placebo
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Newly diagnosed multiple myeloma; 3.Renal insufficiency, defined as serum creatinine >= 177 µmol/L or creatinine clearance <= 40 mL/min; 4.During the screening period, the patient's average hemoglobin (Hb) level over the last three measurements is <8 g/dL; 5.The subject voluntarily participates and signs the informed consent form (ICF) approved by the Ethics Committee (EC);
Exclusion criteria
Exclusion criteria: 1.Coexisting nutritional anemia, such as iron-deficiency anemia, megaloblastic anemia, etc. 2.Known history of conditions that may cause anemia, including myelodysplastic syndrome (MDS), thalassemia, sickle cell anemia, pure red cell aplasia, hemochromatosis, hemosiderosis, thrombotic diseases, or hypercoagulable states. 3.Renal insufficiency requiring dialysis. 4.Suspected or confirmed renal cell carcinoma. 5.Diseases other than multiple myeloma-related renal insufficiency that could lead to renal impairment, including but not limited to glomerulonephritis, diabetic nephropathy, hypertensive glomerulosclerosis, lupus nephritis, Henoch-Schönlein purpura nephritis, tubulointerstitial diseases (chronic interstitial nephritis, chronic pyelonephritis, uric acid nephropathy, etc.), renal vascular diseases, hereditary kidney diseases (polycystic kidney disease, hereditary nephritis, etc.). 6.Any clinically significant infection or evidence of active underlying infection. 7.Positive for HIV, HBsAg, or anti-HCV antibodies. 8.Chronic liver disease. 9.Abnormal liver function, with ALT and AST levels >1.5 times the upper limit of normal. 10.Unstable cardiovascular or cerebrovascular diseases. 11.Uncontrolled hypertension. 12.New York Heart Association (NYHA) Class III or IV congestive heart failure. 13.Myocardial infarction, acute coronary syndrome, stroke, epilepsy, or thromboembolic events within 52 weeks prior to the intervention. 14.Clinically significant gastrointestinal bleeding. 15.Life expectancy <12 months. 16.Blood transfusion within 12 weeks prior to the intervention or anticipated need for transfusion. 17.Treatment with erythropoiesis-stimulating agents within 4 weeks prior to randomization. 18.Intravenous iron supplementation during the screening period or unwillingness to suspend intravenous iron therapy. 19.Pregnant or lactating women. 20.History of other malignancies, except for: cancer considered cured or in clinical remission for 5 years, therapeutically resected basal cell carcinoma or cutaneous squamous cell carcinoma, or carcinoma in situ at any site. 21.Chronic inflammatory diseases that may affect erythropoiesis (e.g., rheumatoid arthritis, systemic lupus erythematosus). 22.Scheduled elective surgery during the study period that may result in significant blood loss. 23.Treatment with androgens, deferoxamine, deferiprone, or other iron chelation therapies within 12 weeks prior to the intervention. 24.Current participation in other clinical trials or residual interference from previously participated clinical studies. 25.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;Proportion of patients receiving rescue therapy (blood transfusion) during the study period;Time to randomization to hemoglobin level of 10 g per deciliter or higher;Proportion of patients with a mean hemoglobin level >=10 g/dL;Proportion of patients with a hemoglobin response (defined as hemoglobin level >=2g per deciliter above baseline); | — |
Countries
China
Contacts
Public ContactCai Zhen; Han Xiaoyan
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed