AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

RecruitingPhase 2Ages 18 Years - 90 YearsAllJin Lu, MD
๐Ÿ’ฌ

In 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.

๐Ÿ“‹ 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 โ‰ฅ 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) โ‰ฅ2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) โ‰ฅ2mg/dL (20 mg/L). โ‘ก. presence of a monoclonal spike that is โ‰ฅ5 g/l. 6. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system). 7. Absolute neutrophil count (ANC) โ‰ฅ1.0 X 10\^9/L, Hemoglobin โ‰ฅ70 g/L, Platelets โ‰ฅ50 X 10\^9/L 8. eGFR โ‰ฅ20 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.
๐Ÿ’Š

What it tests

  • Bortezomib
  • Pomalidomide
  • Dexamethasone
๐Ÿ“

Where

1 site
Peking University People's Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy