Rapid DFLC Response Predict CHR in AL Amyloidosis

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how quickly and deeply patients with systemic AL amyloidosis respond to a specific treatment regimen that includes three medications: daratumumab, bortezomib, and dexamethasone. AL amyloidosis is a rare condition where abnormal proteins build up in organs, and this trial aims to understand if an early response to treatment can predict better outcomes for patients. Researchers want to see if measuring certain blood markers just one week into treatment can help determine who is likely to have a complete response to the therapy.

To participate in this study, individuals must have a confirmed diagnosis of systemic AL amyloidosis and meet other specific health criteria, such as having a certain level of light chains in their blood. The trial is open to adults, regardless of gender, and is currently recruiting participants. Those who join will receive the standard treatment and will be monitored closely to track their response over time. This research is important as it could lead to better treatment strategies and improved care for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• 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.