๐ฌIn plain words
What the trial is, and whether it could suit you
This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.
2. Newly diagnosed or previous treated AL amyloidosis
3. Patients must be โฅ 18 years of age.
4. ECOG performance status 0, 1 or 2.
5. Measurable disease defined by at least one of the following:
โ serum free light chain (FLC) โฅ2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) โฅ2mg/dL (20 mg/L).
โก. presence of a monoclonal spike that is โฅ5 g/l.
6. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
7. Absolute neutrophil count (ANC) โฅ1.0 X 10\^9/L, Hemoglobin โฅ70 g/L, Platelets โฅ50 X 10\^9/L
8. eGFR โฅ20 mL/min/ 1.73 m\^2
9. Written informed consent in accordance with local and institutional guidelines.
10. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
3. Severe or persistent infection that cannot be effectively controlled;
4. Presence of severe autoimmune diseases or immunodeficiency disease;
5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
6. Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.