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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
RECRUITINGFuxing Hospital affiliated to Capital Medical University
Beijing, China
RECRUITINGComplete hematological response
Complete hematological response using ISA criteria
Time frame: 3 months, 6 months
Minimal residual disease
Bone marrow minimal residual disease detected by multi-flow cytometry at the sensitivity of at least 10\^-5.
Time frame: 3 months, 6 months
Stringent dFLC response
dFLC ≤ 10 mg/L
Time frame: 3 months, 6 months
TRAE
Treatment realted adverse events
Time frame: 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.
Time frame: 12 months, 24 months
OS
Overall survival
Time frame: 12 months, 24 months
Renal Response
Renal Response according to ISA criteria
Time frame: 3 months, 6 months, 12 months
Cardiac Response
Cardiac Response according to ISA criteria
Time frame: 3 months, 6 months, 12 months
Hepatic Response
Hepatic Response according to ISA criteria
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Time frame: 3 months, 6 months, 12 months