Autologous Stem Cell Transplantation for Patients With AL Amyloidosis
Autologous Stem Cell Transplantation for Patients With AL Amyloidosis
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.
This study is divided into two parts. In the first part, the investigators retrospectively
 analyze the data of patients with AL amyloidosis who treated with autologous stem cell
 transplantation from July 2010 to December 2019. All patients had a biopsy-proven disease by
 positive Congo red stain with a concomitant demonstration of plasma cell dyscrasia. Organ
 involvement was established according to the criteria established at the 10th International
 Symposium on Amyloid and Amyloidosis. The protocol of ASCT included mobilization with
 colony-stimulating factor alone and conditioning with high-dose melphalan 140 or 200 mg/m2.
 In addition to analyzing the efficacy and safety of all the patients, the investigators also
 analyzed the difference in efficacy between patients in different subgroups. For example,
 subgroups divided according to different induction treatment regimens; subgroups divided
 according to different plasma cell FISH data and FCM data; subgroups divided according to the
 degree of organ involvement, and subgroups divided according to different maintenance
 treatment regimens.

 In the second part of the study, the investigators will conduct a prospective study to
 explore the best autologous stem cell transplantation treatment protocol for AL amyloidosis.
 The protocol includes the induction therapy with bortezomib and daratumumab before ASCT, the
 maintenance treatment with lenalidomide after ASCT, and the treatment options for recurrence
 after transplantation.
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.