Clinical trial NCT06699394: Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis
Official title: Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AL Amyloidosis
Keywords: teclistamab
complete hematological response
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete hematological response
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Minimal residual disease
timeFrame: 3 months, 6 months
measure: Stringent dFLC response
timeFrame: 3 months, 6 months
measure: TRAE
timeFrame: 3 months, 6 months, 12 months
measure: MOD-PFS
timeFrame: 12 months, 24 months
measure: OS
timeFrame: 12 months, 24 months
measure: Renal Response
timeFrame: 3 months, 6 months, 12 months
measure: Cardiac Response
timeFrame: 3 months, 6 months, 12 months
measure: Hepatic Response
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
city: Beijing
country: China
facility: Fuxing Hospital affiliated to Capital Medical University
Study officials:
affiliation: Peking University People's Hospital
name: Jin Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: