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RECRUITINGOBSERVATIONAL

Rapid dFLC Response Predict CHR in AL Amyloidosis

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Diagnosis of systemic AL amyloidosis; 2. Daratumumab, bortezomib, dexamethasone used in treatment; 3. willing to sign a consent form explained to, understood by and signed by the patient; 4. dFLC ≥ 50 mg/L; Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s or weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Dara IV

The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.

DRUG

Bortezomib (drug)

Bortezomib is administered subcutaneously. The dosage range from 0.7 to 1.3 mg/m2 on days 1, 8, 15, and 22 of each cycle, for a maximum of 6 cycles

DRUG

Dexamethasone

Dexamethasone is administered intravenously at a dose of 40 mg weekly for each cycle, for a maximum of 6 cycles. For patients over 70 years of age or with severe edema, heart failure, or uncontrolled diabetes mellitus, dexamethasone can be administered at a dose of 10-20 mg per week.

DRUG

Cyclophosphamide (CTX)

Some patients may receive cyclophosphamide orally or intravenously at a dosage of 300 mg/m2 weekly.

DRUG

Dara SC

The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.

Locations (8)

Peking University People's Hospital
Beijing, Beijing Municipality, China
Fuxing Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Chinese PLA Eastern Theater General Hospital
Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China