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
N/A
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
Researchers are evaluating teclistamab in adults with previously treated immunoglobulin light-chain (AL) amyloidosis. This is a multicenter, open-label phase 2 trial aiming to assess the treatment's benefit in this condition. Participants must have a confirmed diagnosis and meet specific cardiac and genetic testing requirements to ensure accurate disease classification. Teclistamab will be given as a subcutaneous injection. The study does not include placebo groups and focuses on patients who have relapsed after at least one prior therapy including certain drugs like daratumumab and bortezomib. Participants will receive treatment over approximately three months to assess hematologic complete response, with longer follow-up to evaluate overall response until disease progression or death. During the study, participants will undergo regular assessments including blood tests to measure hematologic response, physical exams, and monitoring of organ function. The primary outcome is the rate of hematologic complete response within about three months of treatment. Secondary outcomes include overall response rates monitored for up to 3.5 years. Safety and organ function will be closely observed throughout this period.
CONDITIONS
Brief 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 specific laboratory methods
- Negative genetic testing for transthyretin mutations if hereditary amyloidosis is suspected
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Mayo stage I to IIIA cardiac disease at screening
- Relapsed patients with at least one prior treatment including daratumumab and bortezomib, or high-dose melphalan alone
- Measurable hematologic disease with defined criteria
- Adequate bone marrow function with minimum levels for neutrophils, platelets, and hemoglobin
- Adequate organ function including kidney clearance, liver enzymes, bilirubin levels, and serum albumin
You will not qualify if you...
- Amyloid-specific syndromes like carpal tunnel or skin purpura as only disease evidence
- Isolated soft-tissue involvement
- Presence of non-AL amyloidosis
- Previous treatment with anti-BCMA targeted therapies
- Intolerance to dexamethasone preventing trial treatment
- Multiple myeloma diagnosis requiring treatment, except specific low-risk cases
- Other hematologic malignancies requiring treatment except some low-risk conditions
- Mayo stage IIIB cardiac disease at screening
- Diagnosis of multiple myeloma solely based on serum FLC ratio >100 without other defining events is not exclusionary
- Isolated vascular amyloid in biopsy without systemic amyloidosis indication is excluded
- Patients with certain hematologic malignancies not requiring treatment are excluded except low-risk types noted above
- Exclusion applies to any non-AL amyloidosis conditions
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3.5 years or until disease progression or discontinuation
Participants receive Teclistamab via subcutaneous injection to treat AL amyloidosis.
Repeated visits for dosing and assessments during treatment
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
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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