Rapid dFLC Response Predict CHR in AL Amyloidosis
Recruiting now
Conditions studied: Systemic AL Amyloidosis
In brief
Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.
Key facts
- Study ID
- NCT06627309
- Run by
- Peking University People's Hospital
- People needed
- 50
- Starts
- 2024-10-26
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-09
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of systemic AL amyloidosis;
- Daratumumab, bortezomib, dexamethasone used in treatment;
- Informed consent explained to, understood by and signed by the patient;
- dFLC ≥ 50 mg/L;
You may not qualify if…
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma;
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]); Patients with HIV infection or syphilis infection;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Where it is running
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
- Fuxing Hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (enrolling)
- Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
- First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
- Chinese PLA Eastern Theater General Hospital — Nanjing, Jiangsu, China (enrolling)
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
- The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, China (enrolling)
Full record on ClinicalTrials.gov
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