Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis (NCT07079423) | Clinical Trial Compass
RecruitingPhase 2
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
China35 participantsStarted 2025-06-28
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Stringent difference in involved and uninvolved free light chains (dFLC) response at 1 months after treatment initiation