Brief Summary
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.
Intervention / Treatment
- Drug: Teclistamab
Inclusion Criteria:
- Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry/ immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scana type of medical imaging that uses a radioactive tracer to detect bone conditions or abnormalities is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.
- Genetic testinga procedure that analyses DNA to identify changes in genes, chromosomes and proteins, which can be used to analyse tumour DNA to help determine which treatment has the greatest chance of success must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry/ immunofluorescence/ immunoelectron microscopy/ mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2
- Mayo stage I-IIIA cardiac disease at Screening
- Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.
- Measurable hematologic disease: a dFLC >20 mg/L with an abnormal κ/λ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g/dL.
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:
- Absolute neutrophilsa type of white blood cell that act as a first responder to infections in the body ≥1,000/mm3,
- Platelets ≥75,000/mm3,
- Hemoglobin ≥8.5 g/dL.
- Adequate organ function, defined as:
- Serum creatinine clearance (CKD-EPI formula) ≥20 mL/min,
- Serum SGPT/ALT <5.0 x Upper Limit of Normal (ULN),
- Serum total bilirubin <2.0 mg/dL or direct bilirubin ≤30% of the total, unless the patient has Gilbert’s syndrome, where direct bilirubin should then be <2.0 mg/dL,
- Serum albumin ≥<2.5 gr/dl (medication to correct serum albumin levels is permitted).