Early Blood Test Response Study in Daratumumab-Treated AL Amyloidosis
Checks whether an early blood test predicts full response in people with AL amyloidosis.
Plain-language title generated from the registry record
Registry title: Rapid dFLC Response Predict CHR in AL Amyloidosis
Key facts
- Where
- Beijing, Harbin, Nanjing, Shenyang, and Xi’an, ChinaSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06627309, who can take part
Where in China
- Beijing Anzhen HospitalBeijing, ChinaTaking people
- Fuxing Hospital affiliated to Capital Medical UniversityBeijing, ChinaTaking people
- Peking University First HospitalBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaTaking people
- Chinese PLA Eastern Theater General HospitalNanjing, ChinaTaking people
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaTaking people
- The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT06627309
- Record updated
- 9 March 2026
- Original description
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.Read full original descriptionShow less
Rapid dFLC Response Predict Complete Hematologica Response in Systemic AL Amyloidosis Patients Treated With Daratumumab-based Regimen
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.
Inclusion: 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.
Exclusion: 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; Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma; Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.