Predicting organ response in AL amyloidosis treatment

Rapid dFLC Response Predict Complete Hematologica Response in Systemic AL Amyloidosis Patients Treated With Daratumumab-based Regimen

This study is testing if measuring the quick response of certain proteins in the blood can help predict how well patients with AL amyloidosis will respond to treatment with daratumumab, bortezomib, and dexamethasone.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: Daratumumab, cyclophosphamide
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT06627309 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with systemic AL amyloidosis who are undergoing treatment with daratumumab and meet specific eligibility criteria.

Not a fit: Patients with active multiple myeloma, severe infections, or other advanced malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols and better outcomes for patients with systemic AL amyloidosis.

How similar studies have performed: Previous studies have shown promising results with similar approaches in predicting treatment responses in hematologic conditions, suggesting potential for success in this study.

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.

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• 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)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, China (Recruiting)

Study contacts

• Study coordinator: Yang Liu, M.D.

Conditions Systemic AL Amyloidosis; rapid dFLC response; daratumumab; systemic al amyloidosis