AL Amyloidosis
Conditions
Keywords
teclistamab, complete hematological response
Brief 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.
Detailed description
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.
Interventions
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 effectively controlled; 4. Presence of severe autoimmune diseases or immunodeficiency disease; 5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); 6. Patients with HIV infection or syphilis infection; 7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete hematological response | 3 months, 6 months | Complete hematological response using ISA criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stringent dFLC response | 3 months, 6 months | dFLC ≤ 10 mg/L |
| TRAE | 3 months, 6 months, 12 months | Treatment realted adverse events |
| MOD-PFS | 12 months, 24 months | The time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occurs first. |
| Minimal residual disease | 3 months, 6 months | Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10\^-5. |
| Renal Response | 3 months, 6 months, 12 months | Renal Response according to ISA criteria |
| Cardiac Response | 3 months, 6 months, 12 months | Cardiac Response according to ISA criteria |
| Hepatic Response | 3 months, 6 months, 12 months | Hepatic Response according to ISA criteria |
| OS | 12 months, 24 months | Overall survival |
Countries
China
Contacts
Primary ContactYang Dr, M.D.
Outcome results
None listed