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This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response.
This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.
The treatment of amyloidosis should focus more on complete hematological response (CHR) and organ response rate. We hypothesize that teclistamab can deeply eliminate cloned plasma cells in AL patients, achieving a high proportion of complete hematological response.
In clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14))have been used, the outcome is poor. Also, CHR is correlated with better clinical outcomes. In clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells.
To further explore efficacy and safety, we designed this prospective study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Teclistamab monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teclistamab (Tec) | Drug | Teclistamab is administered subcutaneously with higher step-up doses (SUDs). Patients receive teclistamab with SUDs: 0.2 and 0.7 mg/kg and 1.5 mg/kg in Cycle 1 (2-4 days between doses). 3 mg/kg every 4 weeks will be used in subsequent cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete hematological response | Complete hematological response using ISA criteria | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal residual disease | Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10^-5. | 3 months, 6 months |
| Stringent dFLC response | dFLC ≤ 10 mg/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Dr, M.D. | Contact | +86-10-88326542 | pkuphliuyang@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin Lu, M.D. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Peoples 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 |
|---|---|
| D051416 | Focal Adhesion Protein-Tyrosine Kinases |
| ID | Term |
|---|---|
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
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| 3 months, 6 months |
| TRAE | Treatment realted adverse events | 3 months, 6 months, 12 months |
| MOD-PFS | The time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occurs first. | 12 months, 24 months |
| OS | Overall survival | 12 months, 24 months |
| Renal Response | Renal Response according to ISA criteria | 3 months, 6 months, 12 months |
| Cardiac Response | Cardiac Response according to ISA criteria | 3 months, 6 months, 12 months |
| Hepatic Response | Hepatic Response according to ISA criteria | 3 months, 6 months, 12 months |
| Fuxing Hospital affiliated to Capital Medical University | Recruiting | Beijing | China |
|
| D057165 |
| Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |