Actively Recruiting
Teclistamab-Daratumumab in AL Amyloidosis
Led by Suzanne Lentzsch, MD · Updated on 2025-11-19
25
Participants Needed
1
Research Sites
412 weeks
Total Duration
On this page
Sponsors
S
Suzanne Lentzsch, MD
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.
CONDITIONS
Official Title
Teclistamab-Daratumumab in AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years and able to provide informed consent or have a legally authorized representative consent for you
- Ability to comply with the study protocol as judged by the investigator
- Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry, immunohistochemistry, or immunofluorescence on Congo Red-positive tissue biopsy
- No prior plasma cell clone-directed therapy
- Measurable hematologic disease with either difference between involved and uninvolved serum free light chain (dFLC) of at least 50 mg/L or 5 mg/dL, or serum M-protein of at least 0.5 g/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- One or more organs involved by AL amyloidosis according to consensus guidelines
- Pre-treatment lab values during screening including: absolute neutrophil count at least 0.75 x 10^9/L, hemoglobin at least 8.0 g/dL, platelet count at least 50 x 10^9/L, ALT and AST no more than 2.5 times upper limit of normal, total bilirubin no more than 1.5 times upper limit of normal (except Gilbert syndrome), estimated glomerular filtration rate at least 20 mL/min/1.73 m^2
- For women of childbearing potential: agreement to abstain from heterosexual intercourse or use contraception and refrain from donating eggs
- For men: agreement to abstain from heterosexual intercourse or use a condom and refrain from donating sperm
You will not qualify if you...
- Prior therapy for AL amyloidosis or multiple myeloma except up to 160 mg dexamethasone prior to first treatment day
- Meeting criteria for symptomatic multiple myeloma including lytic bone lesions, plasmacytoma, hypercalcemia without other cause, or bone marrow plasma cell infiltrate over 60%, except those with only involved/uninvolved serum free light chain ratio over 100
- Significant cardiovascular conditions with NT-Pro BNP over 8500 pg/mL or NYHA Class IIIb or IV heart failure
- History of other malignancy affecting study compliance or result interpretation, except certain treated cancers in remission for at least 2 years
- Uncontrolled clinically significant conditions including infections
- Currently on renal replacement therapy
- HIV not on treatment or active hepatitis A, B, or C infection
- Planned stem cell transplant during first 6 treatment cycles (stem cell collection allowed at investigator discretion)
- Known hypersensitivity to study agents
- Receiving any other investigational agent concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
C
Central Nurse Navigator, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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