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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | All patients in this cohort receive daratumumab, bortezomib and dexamethasone as treatment. All patients receive additional sFLC examination in C1D7, C1D14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dara IV | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete hematologic response | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall hematologic response | 6 months | |
| At least one organ response | 12 months | |
| Minimal residual disease |
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Inclusion Criteria:
Exclusion Criteria:
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Systemic AL amyloidosis patients with evaluable hematologic parameter
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu, M.D. | Contact | +86-13716926210 | pkuphliuyang@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China | |
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| ID | Term |
|---|---|
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000686 | Amyloidosis |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D004364 | Pharmaceutical Preparations |
| D003907 | Dexamethasone |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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|
| Bortezomib (drug) | 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 |
|
| Dexamethasone | Drug | 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. |
|
| Cyclophosphamide (CTX) | Drug | Some patients may receive cyclophosphamide orally or intravenously at a dosage of 300 mg/m2 weekly. |
|
| Dara SC | Drug | 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. |
|
Bone marrow miminal residual disease |
| 6 months, 12 months |
| TTNT | Time to next treatment | 12 months |
| MOD-EFS | Major Organ Deterioration Event-Free Survival (MOD-EFS) is defined as the time from the beginning of treatment to hematologic progression, clinical manifestation of end-stage cardiac or renal disease, initiation of subsequent other anti-plasma cell therapy, or death, whichever occur first | 12 months |
| MOD-PFS | Major organ deterioration progression-free survival (MOD-PFS) is defined as the time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occur first | 12 months |
| Fuxing Hospital affiliated to Capital Medical University |
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100045 |
| China |
|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 101118 | China |
|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| First Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
|
| Chinese PLA Eastern Theater General Hospital | Recruiting | Nanjing | Jiangsu | China |
|
| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
|
| The First Affiliated Hospital of Xi'an Jiao Tong University | Recruiting | Xi'an | China |
|
| D057165 |
| Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |