Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

Más betegség

• Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
• Severe or persistent infection that cannot be effectively controlled;
• Presence of severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
• Patients with HIV infection or syphilis infection;

Egyéb

• Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
• Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

• Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.
• Newly diagnosed or previous treated AL amyloidosis
• Patients must be ≥ 18 years of age.
• ECOG performance status 0, 1 or 2.
• Measurable disease defined by at least one of the following:
  • ① serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L).
  • ②. presence of a monoclonal spike that is ≥5 g/l.
• Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
• Absolute neutrophil count (ANC) ≥1.0 X 10\^9/L, Hemoglobin ≥70 g/L, Platelets ≥50 X 10\^9/L
• eGFR ≥20 mL/min/ 1.73 m\^2
• Written informed consent in accordance with local and institutional guidelines.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.