Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
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
| Condition(s) | AL Amyloidosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Diagnosis of systemic AL amyloidosis; 2. Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response; 3. Life expectancy greater than 12 weeks; 4. HGB ≥70g/L; 5. Blood oxygen saturation \> 90%; 6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; 7. Informed consent explained to, understood by and signed by the patient. 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 e |
| Sex | All |
| Lead sponsor | Peking University People's Hospital |
| Locations | Beijing, Beijing Municipality, China; Beijing, China |
| Start date | 2025-03-29 |
| NCT ID | NCT06699394 |
| Official listing | https://clinicaltrials.gov/study/NCT06699394 |