A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

Launched by EUROPEAN MYELOMA NETWORK B.V. · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called teclistamab for people with a condition known as AL amyloidosis, which is a rare disease caused by abnormal protein buildup in the body. Specifically, the trial is looking at patients who have already received treatment for this condition and want to see if teclistamab can help improve their health. This study is open to both men and women, aged 65 to 74, who have a confirmed diagnosis of AL amyloidosis and have had at least one prior treatment, including specific medications.

To be eligible, participants need to have certain lab results showing their disease is measurable and must meet other health criteria, like having good heart and kidney function. During the trial, participants will receive teclistamab and will be monitored for its effects. It’s important to note that the trial is currently not recruiting participants, meaning it hasn't started yet. If you or a loved one are considering this trial, it can be a chance to explore a new possible treatment option for AL amyloidosis.

Gender

ALL

Eligibility criteria

• 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 scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.
• • Genetic testing 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 marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:
• • Absolute neutrophils ≥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).
• Exclusion Criteria:
• • Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.
• • Isolated soft-tissue involvement.
• • Presence of non-AL amyloidosis.
• • Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).
• • Intolerance to dexamethasone that would prohibit treatment with trial therapy.
• • MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering Myeloma, not requiring treatment.
• • Note: A MM diagnosis with a serum FLC ratio \>100, as the only myeloma-defining event, does NOT constitute an exclusion.
• • All hematologic malignancies, with the exception of low-risk Philadelphia chromosome negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic syndromes (MDS), not requiring treatment.
• • Mayo stage IIIB cardiac disease at Screening