platelet reconstruction after autologous stem cell transplantation in multiple myeloma
Conditions
Interventions
experimental group:Ropromostim N01, 3ug/kg administered subcutaneously once a week for up to 6 weeks.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged >= 18 years and diagnosed with multiple myeloma (MM); 2. All patients underwent myeloablative therapy before stem cell transplantation, and the disease remission status before transplantation >=partial response (PR); 3. Adequate organ function is required, defined as follows: 4. Serum bilirubin =40 ml/min (calculated as Cockcroft Gault); 7. LVEF by MUGA or resting echocardiography >= 45%; 8. Pulmonary function (FEV1 and corrected DLCO) >= 45% of predicted. 9. Adequate performance status ECOG <= 2; 10. Able to provide written informed consent; 11. Patients undergoing HDT-AHCT; 12. Patients who are considered by the investigator to be beneficial
Exclusion criteria
Exclusion criteria: 1. Use of other TPO-RA class platelet producing drugs such as ropromostim, eltrombopag, etc. within 2 months prior to enrollment; 2. Concomitant other diseases that cause thrombocytopenia, including ITP, MDS, etc.; 3. Pre-transplant platelet count < 50×10^9/L; 4. Patients with serious concomitant diseases that may interfere with the conduct of clinical trials, such as renal failure requiring hemodialysis, active infection; 5. Patients with a history of symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebrovascular accident or transient ischemic attack, unstable angina pectoris, or cardiac insufficiency within the past 6 months; 6. Patients with thromboembolic disease or patients with thrombosis within half a year (caused by non-interventional procedures); 7. Subjects who, in the opinion of the investigator, are not suitable to participate in the trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days to platelet engraftment ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction events;Number of platelet transfusions and total volume administered;Days to platelet recovery ;Days to neutrophil engraftment; | — |
Countries
China
Contacts
Public ContactGe Jian
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed