AL Amyloidosis
Conditions
Brief summary
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
Teclistamab will be administered via a subcutaneous injection
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation | at 1 months after treatment initiation | Stringent dFLC response is defined as dFLC \< 10 mg/L or involved free light chain (FLC) ≤ 20 mg/L, and FLC will be tested using FreeLite assay (Binding Site). |
Countries
China
Contacts
Primary ContactKaini Shen
Outcome results
None listed