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Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.
The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Response Group | Other | Daratumumab, bortezomib, dexamethasone |
|
| Non-Rapid Response Group | Other | Daratumumab, venetoclax, dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles. Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall CHR rate at 6 months | Overall complete hematologic response rate at 6 months | Overall CHR rate at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac response at 6 months | Cardiac response at 6 months | Cardiac response at 6 months |
| Renal response at 6 months | Renal response at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Lu | Contact | +8613311491805 | jin1lu@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Lu | Peking University People's Hospital | Principal Investigator |
| 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 |
|---|---|
| C556306 | daratumumab |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Bortezomib | Drug | All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles. |
|
| Dexamethasone | Drug | All patients received 20-40 mg oral or intravenous dexamethasone |
|
| Venetoclax | Drug | All patients received venetoclax 400mg daily. |
|
| Renal response at 6 months |
| Hepatic response at 6 months | Hepatic response at 6 months | Hepatic response at 6 months |
| Estimated 2-year PFS | Estimated 2-year progression free survival | Estimated 2-year PFS |
| Estimated 2-year OS | Estimated 2-year overall survival | Estimated 2-year overall survival |
| MRD status at 6 months | Minimal residual disease status at 6 months | MRD status at 6 months |
| TRAEs | treatment-related adverse events up to 6 months | TRAEs |
| Capital Medical University Affiliated Fuxing Hospital | Recruiting | Beijing | Beijing Municipality | 100045 | China |
|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 101118 | China |
|
| Chinese PLA Eastern Theater General Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Qilu Hospital of Shandong University (QingDao) | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Qingdao Municipal Hospital | Recruiting | Qingdao | Shandong | 266011 | China |
|
| The First Affiliated Hospital of Xi'an Jiao Tong University | Recruiting | Xi’an | Shanxi | 710061 | 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 |