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New treatment option for AL Amyloidosis
Official title Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
ClinicalTrials.gov ID: NCT07079423
What this study is testing
What is Teclistamab (Tec)?
Teclistamab (Tec) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for al amyloidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- dFLC ≥ 50mg/L
You likely can't join if
- 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
See the full eligibility criteria
- Biopsy confirmed AL amyloidosis
- Mayo 2004 stage IIIB
- dFLC ≥ 50mg/L
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.