Actively Recruiting
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
Led by European Myeloma Network B.V. · Updated on 2026-04-21
30
Participants Needed
10
Research Sites
165 weeks
Total Duration
On this page
Sponsors
E
European Myeloma Network B.V.
Lead Sponsor
J
Janssen Research & Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab
CONDITIONS
Official Title
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of AL amyloidosis confirmed by immunohistochemistry, immunofluorescence, immunoelectron microscopy, or mass spectrometry
- Negative genetic testing for transthyretin mutations if peripheral neuropathy or heart is the main organ involved
- ECOG performance status of 0, 1, or 2
- Mayo stage I to IIIA cardiac disease at screening
- Relapsed patients must have received at least one prior treatment including daratumumab and bortezomib, with at least two cycles of therapy; patients treated only with high-dose melphalan are also eligible
- Measurable hematologic disease with dFLC >20 mg/L and abnormal kappa/lambda ratio or monoclonal spike ≥0.5 g/dL
- Adequate bone marrow function without transfusions or growth factors within 5 days before first drug dose, defined as absolute neutrophils ≥1,000/mm3, platelets ≥75,000/mm3, hemoglobin ≥8.5 g/dL
- Adequate organ function including creatinine clearance ≥20 mL/min, ALT less than 5 times the upper limit of normal, total bilirubin less than 2.0 mg/dL or direct bilirubin ≤30% of total (except Gilbert's syndrome), and serum albumin ≥2.5 g/dL (medication to correct albumin allowed)
You will not qualify if you...
- Amyloid-specific syndrome such as carpal tunnel syndrome or skin purpura as the only disease evidence
- Isolated soft-tissue involvement
- Presence of non-AL amyloidosis
- Previous anti-BCMA targeted therapy including bispecifics
- Intolerance to dexamethasone preventing treatment
- Multiple myeloma diagnosis requiring treatment, except MGUS or smoldering myeloma
- All hematologic malignancies requiring treatment except low-risk Philadelphia chromosome negative myeloproliferative neoplasms and low-risk myelodysplastic syndromes
- Mayo stage IIIB cardiac disease at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
South Australia Health
Adelaide, Australia
Actively Recruiting
2
Westmead Hospital
Sydney, Australia
Actively Recruiting
3
CHU Limoges
Limoges, France
Actively Recruiting
4
Paris St Louis
Paris, France
Not Yet Recruiting
5
University Hospital Essen
Essen, Germany
Actively Recruiting
6
University Hospital Heidelberg
Heidelberg, Germany
Actively Recruiting
7
University Hospital Würzburg
Würzburg, Germany
Actively Recruiting
8
General Hospital of Athens "Alexandra"
Athens, Greece
Actively Recruiting
9
Fondazione I.R.C.C.S Policlinico "San Matteo"
Pavia, Italy
Actively Recruiting
10
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
C
Chiara Del Pietro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here