Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)

• Status: Completed
• Trial end date: 2016-05-12
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhi-Hong Liu, M.D.
• Collaborators: Nanjing Medical University; Soochow University
• Treatments: Bortezomib; Dexamethasone

Criteria

Inclusion Criteria:

1. Male or female;

2. aged 18-65 years;

3. Patients with newly diagnosed AL;

4. Appropriate for autologous hematopoietic stem cell transplantation;

5. Abnormal M protein or free light chain detected in serum and / or urine

6. ECOG score 0-2 points;

7. Subjects (or their legal representatives) must signed an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.

Exclusion Criteria:

1. Subjects received systematic treatment with steroids

2. Subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment.

3. Pregnant and breastfeeding women;

4. Subjects suffering from multiple myeloma.

5. hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters);

6. Subjects have severe cardiovascular disease,

7. Subjects have serious physical disease and mental illnesses which may interfere the study