Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

Launched by JIN LU, MD · Mar 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—bortezomib, pomalidomide, and dexamethasone—aimed at treating patients with newly diagnosed systemic light chain (AL) amyloidosis, a condition where abnormal proteins build up in the body and can cause serious health issues. The trial will include about 40 participants, and the main goal is to see how well these medications work in improving blood tests that measure the disease's activity after six months of treatment.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of AL amyloidosis. They should have measurable symptoms affecting organs like the heart, kidneys, or nervous system, and their overall health must be stable. Participants can expect to receive these medications and will be closely monitored for their response to the treatment and any side effects. It is important to note that individuals with certain other health conditions, like active infections or other advanced cancers, will not be able to join this study.

Gender

ALL

Eligibility criteria

• 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 ≥ 18 years of age.
• • 4. ECOG performance status 0, 1 or 2.
• 5. 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.
• • 6. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
• • 7. Absolute neutrophil count (ANC) ≥1.0 X 10\^9/L, Hemoglobin ≥70 g/L, Platelets ≥50 X 10\^9/L
• • 8. eGFR ≥20 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.