Multiple Myaloma
Conditions
Interventions
Treatment Group:Participants will receive luspatercept treatment concomitantly with anti-myeloma chemotherapy.
Control Group:Participants will receive placebo treatment concomitantly with anti-myeloma chemotherapy.
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: A total of patients diagnosed and treated for multiple myeloma at our center between April 2026 and October 2026 will be included, with the specific criteria as follows: 1. Age = 18 years. 2. Estimated life expectancy > 6 months. 3. Definitive diagnosis of multiple myeloma. 4. No prior anti-myeloma therapy. 5. Adequate general condition, with an ECOG performance status of 0–2. 6. Baseline hemoglobin level < 80 g/L prior to treatment.
Exclusion criteria
Exclusion criteria: 1. Concomitant other malignancy, or presence of suspected malignant lesions. 2. Uncontrolled systemic infection; active hepatitis B or hepatitis C infection; or HIV infection. 3. Significant organ dysfunction, including: (1) Cardiac dysfunction:uncontrolled angina or arrhythmia; acute decompensated heart failure or NYHA class III–IV heart failure; or myocardial infarction within the past 6 months. (2) Renal dysfunction: estimated glomerular filtration rate (eGFR) 3 × the upper limit of normal (ULN). (4) Any other major disease history that may place the subject at risk or interfere with study participation or assessments. 4. Pregnant or breastfeeding women. 5. Other causes of anemia, including iron/vitamin B12/folate deficiency; autoimmune or hereditary hemolytic anemia; thalassemia; hypothyroidism; significant bleeding; or drug-induced anemia. 6. Treatment with erythropoiesis-stimulating agents (ESAs) within 8 weeks prior to study initiation. 7. Planned local radiotherapy during the study period. 8. Prior treatment with luspatercept or sotatercept. 9. Exposure to cytotoxic drugs within 8 weeks prior to enrollment. 10. History of severe hypersensitivity to luspatercept. 11. Major surgery within 3 months or minor surgery within 2 weeks prior to enrollment. 12. Deep vein thrombosis (DVT) or stroke requiring medical intervention within the past 6 months. 13. Chronic anticoagulant therapy within 4 weeks prior to enrollment. 14. Platelet count > 1000 × 10?/L or < 50 × 10?/L; absolute neutrophil count (ANC) < 0.5 × 10?/L. 15. Uncontrolled hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin level from baseline (increase from baseline); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with hemoglobin = 100 g/L at the end of each treatment cycle;Cumulative number of red blood cell transfusions and total transfused units during induction therapy;FACIT-Fatigue scale score at the end of each treatment cycle;Estimated (theoretical) hospitalization costs during luspatercept/placebo treatment;Overall response rate (ORR) after completion of induction therapy (IMWG 2016 criteria);Incidence of treatment-emergent adverse events; | — |
Countries
China
Contacts
Public ContactLi Juan
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed