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A noninterventive, two-way cohort single center study to evaluate the efficacy and safety of thymosin a1 in preventing infection in patients with multiple myeloma

A noninterventive, two-way cohort single center study to evaluate the efficacy and safety of thymosin a1 in preventing infection in patients with multiple myeloma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066430
Enrollment
Unknown
Registered
2022-12-05
Start date
2022-12-12
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma

Interventions

Thymosin a1 group:No intervention
No thymosin a1 group:No intervention

Sponsors

Department of Hematology, The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients must meet all the following conditions to be selected: 1. Age>=18, regardless of gender 2. a. Patients with newly diagnosed multiple myeloma treated for the first time b. MM patients within+30d -+60d after autologous HSCT transplantation 3. Generally: ECOG score<3 4. No important organ function damage: a. Serum AST, ALT=<3 times the upper normal limit b. Total bilirubin=<3 times the upper limit of normal value c. Serum creatinine=<3 times the upper limit of normal value d. ECG Q-T interval=<450ms

Exclusion criteria

Exclusion criteria: Patients with one of the following conditions cannot be selected: 1. Patients in thymosin a1 group were in the course of infection or anti infection when they first used thymosin a1 2. Patients in thymosin a1 group had known immediate or delayed hypersensitivity reaction history to similar drugs and excipients of the study drug 3. Chronic renal failure requiring hemodialysis or peritoneal dialysis 4. Known or suspected cirrhosis, portal hypertension, chronic jaundice or chronic ascites 5. Human immunodeficiency virus infection 6. History of lung, liver, kidney or small intestine transplantation 7. Pregnancy or breastfeeding 8. Patients who refused to take effective contraceptive measures during the study 9. Due to uncorrectable medical conditions, such as poor tumor control or other end-stage diseases, the patient is not expected to survive for 3 months 10. Participate in other interventional clinical studies at the same time 11. Conditions that other researchers think cannot be included in the group

Design outcomes

Primary

MeasureTime frame
Total number of infections during observation;

Secondary

MeasureTime frame
Duration of infection;Time to first infection after enrollment;Antibacterial/viral/fungal drug use time;Number of serious infections;Multiple drug resistant bacteria infection times;The average hospitalization days;Infection rate;Infection rate of multi drug resistant bacteria;Objective response rate;Complete response rate;Progression free survival;overall survival;Total hospitalization expenses;

Countries

China

Contacts

Public ContactLiXin

Department of Hematology, The Third Xiangya Hospital of Central South University

972978226@qq.com+86 13808418932

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026