Recruiting NCT07079423
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teclistamab (Tec).
- Who it may be relevant to
- Registry conditions: AL Amyloidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study
Overview
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
Interventions
- Drug Teclistamab (Tec)
Teclistamab will be administered via a subcutaneous injection
Primary outcome measures
- Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation [Time frame: at 1 months after treatment initiation]
Eligibility criteria
Inclusion criteria
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- dFLC ≥ 50mg/L
Exclusion criteria
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07079423 · TEC-IIIB AL