Tests teclistamab in newly diagnosed people with AL amyloidosis
Tests teclistamab in adults newly diagnosed with Mayo stage IIIB AL amyloidosis.
Plain-language title generated from the registry record
Registry title: Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07079423
- Record updated
- 23 July 2025
- Original description
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamabRead full original descriptionShow less
Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study
This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab
Inclusion: Biopsy confirmed AL amyloidosis; Mayo 2004 stage IIIB; dFLC ≥ 50mg/L.
Exclusion: Co-morbidity of uncontrolled infection; Co-morbidity of other active malignancy; Hepatitis B virus (HBV)-DNA > 1000 copies/mL; Seropositive for hepatitis C (except in the setting of a sustained virologic response); Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L; Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) > 5 × upper limit of normal (ULN), total bilirubin > 2 × ULN, estimated glomerular filtration rate < 20 mL/min, or receiving renal replacement therapy; Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia; Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker); Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia; Seropositive for human immunodeficiency virus.