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Rapid dFLC Response Predict CHR in AL Amyloidosis

Recruitingn/aAges 18 Years - 99 YearsAllPeking University People's Hospital
NCT06627309 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 treatm

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dara IV
  • Bortezomib (drug)
  • Dexamethasone
  • Cyclophosphamide (CTX)
  • Dara SC
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Where

8 sites
Peking University People's Hospital
Beijing, China
Fuxing Hospital affiliated to Capital Medical University
Beijing, China
Beijing Anzhen Hospital
Beijing, China
Peking University First Hospital
Beijing, China
First Affiliated Hospital of Harbin Medical University
Harbin, China
Chinese PLA Eastern Theater General Hospital
Nanjing, China
Shengjing Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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