Predicting organ response in AL amyloidosis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients diagnosed with systemic AL amyloidosis who are receiving treatment with daratumumab, bortezomib, and dexamethasone. It aims to evaluate the rapid response of free light chains (dFLC) as a predictor of complete hematologic response and overall organ response. The study will analyze the correlation between the speed of hematologic response and patient outcomes, particularly in cases with significant organ involvement. The findings could enhance treatment strategies and patient management in AL amyloidosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of systemic AL amyloidosis;
2. Daratumumab, bortezomib, dexamethasone used in treatment;
3. Informed consent explained to, understood by and signed by the patient;
4. dFLC ≥ 50 mg/L;

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 \[HCVRNA+\]); Patients with HIV infection or syphilis infection;
6. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fuxing Hospital affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• First Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• Chinese PLA Eastern Theater General Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yang Liu, M.D.
• Email: pkuphliuyang@bjmu.edu.cn
• Phone: +86-13716926210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.