This study mainly evaluated the efficacy and safety of autologous stem cell transplantation for the treatment of AL amyloidosis, the role of induction and maintenance therapy in autologous stem cell transplantation, and the long-term efficacy and prognosis risk factors of autologous stem cell transplantation for the treatment of AL amyloidosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female;
* aged 18-75 years;
* Patients with newly diagnosed AL;
* Appropriate for autologous hematopoietic stem cell transplantation;
* Abnormal M protein or free light chain detected in serum and/or urine
* ECOG score 0-2 points;
* Subjects (or their legal representatives) must sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
Exclusion Criteria:
* Pregnant and breastfeeding women;
* Subjects suffering from multiple myeloma;
* hypersensitivity to any treatment drugs;
* Subjects have severe cardiovascular disease;
* Subjects have a serious physical disease and mental illnesses;
* Other conditions that researchers consider are not suitable for transplantation.
Primary outcome measure(s)
overall survival — 5 years the 5 years overall survival after autologous stem cell transplantation.
progression-free survival — 5 years the 5 years progression-free survival after autologous stem cell transplantation.
hematological complete response rate — 1 year the 1 year hematologic complete response rate after autologous stem cell transplantation.
organ response rate — 1 year the 1 years organ response rate after autologous stem cell transplantation.
Trial sites (1)
Facility
City
Region
Status
National Clinical Research Center of Kidney Diseases, Jinling Hospital
Nanjing
Jiangsu
More Nanjing University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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