Last updated: August 24, 2022
Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
Cancer
Bone Neoplasm
Lymphoproliferative Disorders
Treatment
N/AClinical Study ID
NCT05517213
307-947168-89
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Confirmed MM patients: patients who were initially diagnosed and treated, who weresuitable for autologous transplantation and planned to be treated with ASCT;
- Age limitation: 18-70 years old patients; ④ Physical status: ECOG physical statusscore was 0 or 1; ⑤ The adverse reactions caused by chemotherapy had recovered:peripheral blood leukocytes ≥3.0×109/L, hemoglobin ≥80g/L, platelet ≥80×109/L;Liver function glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase ≤ 2 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upperlimit of normal value, serum creatinine ≤ 1.5 times the upper limit of normalvalue, chest CT normal, ecg normal; (5) Patients participate voluntarily andinformed consent is signed by patients themselves (or their legalrepresentatives); Take effective contraceptive measures during the childbearingage.
Exclusion
Exclusion Criteria:
① According to the clinical judgment of the researcher: According to NCI CTCAE (4th editionMay 28, 2009), patients with ≥3 grade cardiopulmonary insufficiency and severe kidneydisease, currently diagnosed as coronary heart disease, myocardial infarction, arrhythmia,glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase ≥ 2 times the upper limitof normal value, Total bilirubin ≥ 1.5 times the upper limit of normal;
- With active infection, including fever of unknown cause (axillary temperature > 37.5℃); ③ Patients with severe history of mental system.
Study Design
Total Participants: 164
Study Start date:
February 01, 2022
Estimated Completion Date:
October 01, 2025
Study Description
Connect with a study center
Hospital 307
Beijing, Beijing 100071
ChinaActive - Recruiting
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